[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-bowel-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-bowel-disease":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,45,57,94,121,143,167,187,219,244,268,295,315,340,374,402,433,458,486,512,532,556,576,598,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053628","longitudinal-immunophenotyping-of-patients-with-inflammatory-bowel-disease-100053628",false,"NCT07619547","Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAffected Participant cohort:\n\n1. Adults 18 - 85 years of age\n2. History of:\n\n   1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and\u002For\n   2. a defined genetic syndrome\u002Fmutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n3. Presence of a referring community physician who would be able to manage care outside of NIH\n\nUnaffected family member of participant:\n\nImmediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD\n\n1. Adults 18 - 99 years of age\n2. In good general health\n3. No medical diagnosis of IBD\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable or unwilling to provide informed consent\n2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures","ALL","18 Years","85 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","Background:\n\nInflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.\n\nObjective:\n\nTo better understand IBD over time.\n\nEligibility:\n\nAdults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have clinic visits every 6 months for 3 years.\n\nOnce a year, they will have these procedures:\n\nA physical exam with blood and stool samples.\n\nUltrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.\n\nMagnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.\n\nColonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.\n\nUpper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.\n\nQuestionnaires. Participants will answer questions about their disease and their diet.\n\nMidyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires\n\nHealthy relatives will have 1 blood draw for genetic tests.",[25,26,27],"Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis",[29,30,31],"Immune System","Inflammation","gastroenterology","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-07-16",{"date":40,"type":21},"2036-06-01",{"name":42,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":46,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":48,"keywords":49,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":56,"locationsCount":44},"100641419",{"count":20,"type":21},[25,26,27],[29,30,31],"2026-07-01",{"date":52,"type":36},"2026-07-02",{"date":54,"type":21},"2026-07-07",{"date":40,"type":21},{"name":42,"class":43},{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":65,"type":21},300,"INTERVENTIONAL",[68],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[71,72,73,74,25,75,76,77,78,79,80,81,82,27],"Autoimmune Disease","Crohn Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Systemic Scleroderma","RECRUITING","2026-06-16",{"date":86,"type":36},"2026-06-17",{"date":88,"type":36},"2019-07-16",{"date":90,"type":21},"2028-03-30",{"name":92,"class":43},"National Cancer Institute (NCI)",52,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":101,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":66,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"100642832","phase-4-a-study-to-measure-mirikizumab-levels-in-breast-milk-of-lactating-participants-receiving-mirikizumab-therapeutically-for-an-approved-indication-100642832","NCT07612267","A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication","A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication","Inclusion Criteria:\n\nStudy Participants:\n\n* Mothers who are at minimum 18 years of age and their infants who are at least 36 weeks gestation age at birth and at least 3 weeks old by Study Day 0\n* Multiple births may be allowed following discussion with the medical monitor.\n\nNote: in the opinion of the healthcare practitioner (HCP), there are no infant or maternal issues that would preclude the mother participant or the infant from participation\n\n* Lactation history is well established, with the mother exclusively breastfeeding her infant\n* Mother participant is receiving mirikizumab therapeutically for an approved diagnosis (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0)\n* Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula\n\nExclusion Criteria:\n\n* Have a history of inadequate lactation, for multiparous participants who have previously breastfed\n* Have a significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking mirikizumab, or of interfering with the interpretation of data\n* Have any condition that fulfills any contraindication stated in the label. All warnings and precautions stated in the label need to be considered\n* Have a history of breast augmentation procedures judged to have a clinical impact on breast milk expression such as breast reduction surgery and some breast implants, or current evidence of acute or chronic conditions affecting breasts and potentially interfering with breast milk collection\n* Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before enrollment or intend to receive a live vaccine during the study or an inactivated vaccine 2 weeks postdose, the mother participant must be given the vaccine at an injection site remote from mirikizumab administration","FEMALE","3 Weeks",{"count":104,"type":21},14,[106],"PHASE4","The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.\n\nParticipation in this study could last up to 94 days, including screening and follow-up period.",[109,25],"Lactation","2026-06-11",{"date":112,"type":36},"2026-06-15",{"date":114,"type":21},"2026-06",{"date":116,"type":21},"2028-09",{"name":118,"class":119},"Eli Lilly and Company","INDUSTRY",22,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":44},"100633863","a-study-to-assess-real-world-outcomes-for-long-term-use-of-guselkumab-100633863","NCT07532213","A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab","Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes","LUNAR","Inclusion Criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration (but after treatment decision by physician)\n* Must have confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records\n* Must sign a participation agreement\u002FInformed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":130,"type":21},50,"The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[25,133,72],"Colitis, Ulcerative","2026-06-10",{"date":136,"type":36},"2026-06-12",{"date":138,"type":36},"2026-04-13",{"date":140,"type":21},"2029-04-10",{"name":142,"class":119},"Janssen-Cilag A.G., Switzerland",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":66,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":166},"100483773","a-randomized-crossover-trial-of-bright-light-therapy-in-crohns-disease-on-intestinal-barrier-homeostasis-100483773","NCT05579392","A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis","Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis","Inclusion Criteria:\n\n1. Biopsy proven diagnosis of Crohn's or Ulcerative Colitis\n2. 18 years or older\n3. Fecal Calprotectin \\> 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50\n4. Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks\n\nExclusion Criteria:\n\n1. Active IBD (Harvey Bradshaw Index \\> 5 or Modified Harvey Bradshaw Index \\>5)\n2. Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)\n3. Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)\n4. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))\n5. Regular use of medications that affect intestinal permeability, and\u002For endogenous melatonin including metoclopramide, NSAIDs, beta blockers, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study\n6. People who have worked night shifts or crossed more than 2 time zones in the previous month\n7. Any major organ disease - renal impairment (creatinine\\>1.2 mg\u002FdL), diabetes (Hgb-A1c \\> 6.5%); liver disease (LFTs \\> 1.5x normal), or significant cardiac failure (NY classification stage III\u002FIV)\n8. Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening\n9. Inability to sign an informed consent",{"count":151,"type":21},30,[153],"NA","Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are two of the most significant chronic conditions of the gastrointestinal tract (GIT) and affects over 1.5 million individuals in the U.S. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor. We, therefore, hypothesize that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).",[25],"2026-06-05",{"date":158,"type":36},"2026-06-09",{"date":160,"type":36},"2022-09-22",{"date":162,"type":21},"2026-10-31",{"name":164,"class":165},"Rush University Medical Center","OTHER",2,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":44},"100611566","a-study-to-observe-real-world-evidence-of-guselkumab-treatment-in-participants-with-ulcerative-colitis-and-crohns-disease-in-the-united-kingdom-uk-100611566","NCT07242248","A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)","Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK","GUSTO-UK","Inclusion Criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's\u002F Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)\n* Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records\n* Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion Criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included\n* Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and \u002For small molecules)\n* Is unable to provide informed consent",{"count":176,"type":21},220,"The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[25,133,26],"2026-06-04",{"date":156,"type":36},{"date":182,"type":36},"2025-11-17",{"date":184,"type":21},"2029-03-17",{"name":186,"class":119},"Janssen-Cilag Ltd.",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":44},"100600813","a-study-to-generate-real-world-evidence-of-guselkumab-effectiveness-in-inflammatory-bowel-disease-in-germany-100600813","NCT07102368","A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany","Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects","GORGEOUS","Inclusion Criteria:\n\n1. Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics\n2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements\n3. By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study\n\nExclusion Criteria:\n\n1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy\n2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included\n3. Has had a colectomy and\u002For a pouch\n4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \\& Johnson (J\\&J)",{"count":196,"type":21},500,"The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.",[25,133,26],[200,27,26,201,202,203,204,205,206,207,133,208,209,210,211],"IBD","Gastroenteritis","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Pathologic Processes","Inflammatory Bowel Diseases","Ulcer","Guselkumab","Tremfya","Inflammatory",{"date":156,"type":36},{"date":214,"type":36},"2025-08-18",{"date":216,"type":21},"2029-01-15",{"name":218,"class":119},"Janssen-Cilag G.m.b.H",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":44},"100420181","testing-of-an-educational-tool-for-patients-with-melanoma-and-pre-existing-autoimmune-disease-who-are-candidates-for-immune-checkpoint-inhibitors-100420181","NCT04751396","Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors","Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors: Acceptability and Usability With Patients and Providers","Inclusion Criteria:\n\n* Diagnosis of melanoma\n* Diagnosis of pre-existing autoimmune disease\n\n  * Inflammatory bowel disease\n\n    * Diagnosis of Crohn's disease or ulcerative colitis by a gastroenterologist\n    * For ulcerative colitis, proof of chronic changes over time (i.e., 6 months) and signs of inflammation histologically\n    * Treatment with aminosalicylates, corticosteroids, thiopurines, or immune modifiers (e.g., calcineurin inhibitors, methotrexate, adhesion molecule antagonists)\n  * Rheumatoid arthritis\n\n    * Diagnosis of rheumatoid arthritis by a rheumatologist\n    * Treatment with traditional disease-modifying antirheumatic drugs (e.g., methotrexate, sulfasalazine, hydroxychloroquine) or targeted therapy\n  * Systemic lupus erythematosus\n\n    * Diagnosis of systemic lupus erythematosus by a rheumatologist\n  * Psoriasis\n\n    * Diagnosis of psoriasis by a dermatologist\n    * Treatment with corticosteroids, vitamin D analogs, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, coal tar, or moisturizers; light therapy, including sunlight, ultraviolet B (UVB) phototherapy, narrowband UVB therapy, Goeckerman therapy, photochemotherapy, excimer laser, or pulsed dye laser; or systemic medications, including retinoids, methotrexate, cyclosporine, hydroxyurea, or thioguanine or targeted therapies\n  * Spondyloarthropathies\n\n    * Diagnosis of ankylosing spondylitis, reactive arthritis, psoriatic arthritis, or enteropathic arthritis\u002Fspondylitis by a rheumatologist\n    * Treatment with disease-modifying antirheumatic drugs (e.g., sulfasalazine) or targeted therapy\n* Age of 18 years or older\n* Patients whose physicians had recommended they begin using any of the currently available immune checkpoint inhibitors or people who are in the midst of or have already made the decision on whether or not start an immune checkpoint inhibitor\n* E-mail access and computer with Internet access or telephone\n* Ability to communicate in English or Spanish\n* CLINICIAN\n* Prescribed immune checkpoint inhibitors\n* Are providing care for patients with melanoma\n* In the clinics at MD Anderson",{"count":227,"type":21},125,"This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.",[230,71,72,231,232,25,233,77,78,234,79,81,27],"Ankylosing Spondylitis","Enteropathic Arthritis","Enteropathic Spondylitis","Melanoma","Reactive Arthritis","2026-05-18",{"date":237,"type":36},"2026-05-20",{"date":239,"type":36},"2022-04-20",{"date":241,"type":21},"2027-02-02",{"name":243,"class":165},"M.D. Anderson Cancer Center",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":251,"sex":16,"minAge":17,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":66,"phases":255,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":44},"100553229","early-phase-1-a-clinical-study-of-sph7854-granules-in-healthy-subjects-100553229","NCT06483373","A Clinical Study of SPH7854 Granules in Healthy Subjects.","A Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability\u002FSafety\u002FPharmacokinetics of SPH7854 Granules in Healthy Subjects.","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；\n2. Healthy volunteers;\n3. Before receiving the investigational drug, the examination results were normal or clinically insignificant;\n4. Subjects who have no fertility plan\u002Fsperm donation\u002Fegg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.\n\nExclusion Criteria:\n\n1. Female subjects who are breastfeeding or have positive pregnancy results;\n2. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;\n3. Subjects suffering from allergic diseases or having a history of severe allergies;\n4. Subjects who took the drug or food prohibited by the protocol prior to the first dose;\n5. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;\n6. Other circumstances that meet the protocol exclusion criteria.",true,"45 Years",{"count":254,"type":21},111,[256],"EARLY_PHASE1","To evaluate the safety of SPH7854 in healthy subjects.",[25],"2026-04-29",{"date":261,"type":36},"2026-05-05",{"date":263,"type":36},"2024-05-28",{"date":265,"type":21},"2026-12-31",{"name":267,"class":119},"Shanghai Pharmaceuticals Holding Co., Ltd",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":16,"minAge":276,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":66,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":44},"100603951","the-edict-trial---therapy-for-inflammatory-bowel-disease-flares-100603951","NCT07143188","The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares","Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial","EDICT","Inclusion Criteria:\n\n* adults with an established diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are being treated in the outpatient setting for an Inflammatory bowel disease (IBD) flare, defined as a clinically significant increase in IBD symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea, joint pain, fever, bleeding, unintended weight loss).\n\nExclusion Criteria:\n\n* Patients requiring admission to the hospital for treatment of a flare\n* Patients with allergies to any ingredients in the mBIOTA Elemental Diet\n* Female patients who are pregnant\n* Patients with diabetes who are taking insulin as part of their treatment plan\n* Patients with other medical conditions or personal preferences that would compromise their ability to adhere to the elemental study","21 Years",{"count":278,"type":21},42,[153],"Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic inflammatory conditions of the gastrointestinal tract that affect millions of people in the United States of America. Among patients with IBD, symptomatic flares are quite common; up to 40-50% of patients in some populations report having a flare at least once per month. For most patients with IBD flares, the typical outpatient treatment consists of corticosteroids and, in some instances, initiation of or switching between 5-aminosalicylic acid-acid preparations, immunomodulators, or biologics. These treatments, while often effective, can have harmful side effects, especially when used for long durations of time. Therefore, alternative treatments are highly sought after by both patients and providers.",[25],[283,284,285],"crohn's disease","ulcerative colitis","chronic gastrointestinal tract inflammation","2026-04-22",{"date":288,"type":36},"2026-04-23",{"date":290,"type":21},"2026-08",{"date":292,"type":21},"2026-12",{"name":294,"class":165},"Wake Forest University Health Sciences",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":66,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":44},"100608872","impact-of-morning-light-therapy-in-ibd-100608872","NCT07207200","Impact of Morning Light Therapy in IBD","The Effects of Morning Light Therapy on IBD Activity and Symptoms","Inclusion Criteria:\n\n* Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin \\>150 mcg\u002Fg and\u002For CRP \\>5)\n\nExclusion Criteria:\n\n* Known pregnancy or currently lactating women\n* Current malignancy or active treatment for previously diagnosed malignancy. Patients with squamous and basal cell cancer of the skin are eligible for the study.\n* Serious co-morbidity including: Immunodeficiency, recent myocardial infarction or stroke, history of renal or hepatic failure, infection such as abscess, opportunistic infection, or sepsis.\n* Patients with pacemaker or defibrillators\n* The use of medications known to affect autonomic nervous system function, including but not limited to beta-blockers and benzodiazepines.\n* Comprehension of the English language not adequate to understand the questionnaires\n* Recent changes in IBD directed therapies within the last 3 months\n* Regular use of antidiarrheal agents.\n* Regular use of medications that have been shown to impair sleep (e.g. steroids, stimulants). If willing (and medically appropriate) to washout for 4 weeks, participant can be then enrolled in the study\n* Regular use of sleep medications including but not limited to: benzodiazepine hypnotics, non-benzodiazepine hypnotics, antipsychotics, and melatonin. If willing (and medically appropriate) to washout for 4 weeks, participant can be then enrolled in the study\n* Patients with prior colectomy or total proctocolectomy\n* History of any surgery within 3 months\n* Untreated Obstructive Sleep Apnea\n* Blindness or severely impaired, uncorrected vision\n* Employment which includes nocturnal shift work\n* Traveling multiple time zones within the study time frame\n* Any marijuana or illicit drugs use within one month of enrollment or ongoing basis",{"count":151,"type":21},[153],"The pilot study will focus on the effects of morning light therapy (MLT) in adult patients with ulcerative colitis (UC) who have evidence of poor sleep quality and active inflammation. The specific population is at risk for circadian rhythm sleep-wake disorders and has significant potential benefit from circadian realignment, which may lead to improved sleep quality and, ultimately, UC-related inflammatory activity. During an initial one-week lead-in period, participants will obtain baseline circadian-related labs, complete symptom-related surveys, and use a wearable device continuously to obtain baseline sleep-wake data. After the lead-in week, patients will undergo one hour of MLT while wearing wearable devices continuously and completing daily symptom surveys. At the end of four weeks of MLT, patients will obtain post-intervention circadian and inflammatory assessments in addition to completing the same symptom-related surveys.",[25],"2026-03-11",{"date":308,"type":36},"2026-03-13",{"date":310,"type":21},"2026-03",{"date":312,"type":21},"2027-07-01",{"name":314,"class":165},"Icahn School of Medicine at Mount Sinai",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":66,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":339},"100609132","testing-the-impact-of-measurement-based-care-on-quality-of-life-and-disease-management-among-veterans-with-inflammatory-bowel-disease-100609132","NCT07210580","Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease","Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study","MBC-IBD","Inclusion Criteria:\n\nInclusion criteria for Veteran patients include:\n\n* receiving IBD care at one of the four sites\n* reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ\\\u003C60, as used by others)\n* willingness and ability to participate in study procedures\n\nClinic staff criteria:\n\n* relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland).\n\nExclusion Criteria:\n\nVeteran Patient Exclusion criteria:\n\n* Presence of an ostomy or ileal-pouch anal anastomosis\n* Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant).\n* Exclusions can be readily determined from chart review and a baseline patient assessment\n\nClinic staff exclusion criteria:\n\n* Clinic staff without any experience with MBC in IBD.",{"count":324,"type":21},250,[153],"This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.",[25],[329,25],"Measurement Based Care","2026-03-10",{"date":306,"type":36},{"date":333,"type":36},"2026-03-09",{"date":335,"type":21},"2029-09-30",{"name":337,"class":338},"VA Office of Research and Development","FED",4,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":66,"phases":350,"briefSummary":352,"conditions":353,"keywords":361,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100562168","phase-2-covid-19-booster-and-iiv-schedule-in-immunocompromised-hosts-100562168","NCT06599658","COVID-19 Booster and IIV Schedule in Immunocompromised Hosts","The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts","CO2I2","Inclusion Criteria:\n\n\\- All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:\n\na) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\\<200 cells\u002FµL in the last 6 months, iv) CD4%\\<15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.\n\nExclusion Criteria:\n\n* Potential participants who meet ANY of the following criteria will be excluded:\n\n  i. Received any of the following:\n  1. Annual vaccination against influenza \\< 6 months ago\n  2. COVID-19 booster \\< 3 months ago ii. History of any of the following:\n\n  \u003C!-- -->\n\n  1. life-threatening reaction any component of the IIV or COVID-19 vaccines\n  2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination\n  3. Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \\< 6-months ago; vi. Unable to provide informed consent",{"count":349,"type":21},660,[351],"PHASE2","The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).\n\nThe main questions it aims to answer are:\n\n1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?\n2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?\n\nResearchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.\n\nPeople living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.",[354,355,356,357,25,358,359,360],"COVID 19","Influenza","Rheumatoid Arthritis (RA)","Systemic Lupus Erthematosus","Solid Organ Transplant Recipients","Immunocompromised Host","People Living With HIV",[362,363,364],"Vaccine","Immunogenicity","Safety","2026-03-06",{"date":330,"type":36},{"date":368,"type":36},"2024-11-20",{"date":370,"type":21},"2027-03-31",{"name":372,"class":165},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",3,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":66,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":44},"100333007","the-influence-of-a-fasting-mimicking-diet-on-ulcerative-colitis-100333007","NCT03615690","The Influence of a Fasting Mimicking Diet on Ulcerative Colitis","Inclusion Criteria:\n\n* Mild to moderate Ulcerative Colitis on the partial Mayo Score out of 9 (score between 2 to 7)\n* Age of 18-70 at start of study (inclusive)\n\nExclusion Criteria:\n\n* Women who are pregnant or nursing or expect to be pregnant\n* Individuals allergic to nuts\n* Individuals with a body mass index (BMI) lower than 18\n* Individuals diagnosed with a serious medical condition as defined by the patient's physician, unless approved in writing by a physician\n* Individuals who have been severely weakened by a disease or medical procedure,\n* Individuals who are taking medication which may not be safely consumed with a calorie restricted diet\n* Individuals with diabetes who are taking anti-diabetic drugs associated with risk of hypoglycemia\n* Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician\n* Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \\\u003C 40%)\n* Individuals with a history of syncope\n* Individuals with dietary needs incompatible with the FMD meal plan\n* Individuals with liver or kidney disorders that may be affected by very low glucose and protein content of the diet.\n* Patients on a caloric restricted diet will also be excluded.\n* Patients with relevant prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, hemi- or total colectomy, proctocolectomy, ileoanal pouch will be excluded.","70 Years",{"count":382,"type":21},75,[153],"The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC). The diet may allow users to receive the benefits of fasting while also being able to enjoy food (the ingredients of which are GRAS (generally recognized as safe) by the Food and Drug Administration (FDA). Research on dietary interventions and UC are very limited. Fasting mimicking diets (FMD) have been studied with support of the National Institute of Health and published in leading journals. This research investigates whether markers of inflammation decrease and\u002For quality of life increases after three cycles of a five-day period of the fasting mimicking diet, and may provide rationale for its use to treat UC.",[25,386,27],"Diet Modification",[284,200,388,389,390,391,392],"diet","fasting","fasting mimicking diet","UC","intermittent fasting","2026-02-23",{"date":395,"type":36},"2026-02-27",{"date":397,"type":36},"2020-12-15",{"date":399,"type":21},"2028-12",{"name":401,"class":165},"Stanford University",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100623008","integrating-vaccination-into-hospital-care-pathways-for-vulnerable-patients-100623008","NCT07391046","Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients","Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients: A Scalable and Sustainable Model","AMBU-VAX","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Presence of at least one chronic or immunocompromising condition eligible for vaccination according to national guidelines\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Conditions not included among the predefined eligibility criteria",{"count":411,"type":21},1500,"AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting.\n\nThe study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services.\n\nThe study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.",[414,415,416,417,418,419,420,421,25,422,423],"Chronic Disease","Immunocompromised","HIV Infection","Chronic Kidney Disease","Solid Organ Transplantation","Hematopoietic Stem Cell Transplantation","Cancer","Autoimmune Diseases","Asplenia","Frailty","2026-01-29",{"date":426,"type":36},"2026-02-05",{"date":428,"type":21},"2026-02",{"date":430,"type":21},"2027-02",{"name":432,"class":165},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":251,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":44},"100612349","gut-microbiota-in-ibd-with-comorbid-depressive-disorder-100612349","NCT07252427","Gut Microbiota in IBD With Comorbid Depressive Disorder","Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder","Inclusion Criteria:\n\nIBD with Depressive Disorder Group:\n\n1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).\n2. History of depressive disorder diagnosis or previous use of antidepressant medications.\n3. Age ≥ 18 years.\n4. Willingness to participate and provision of written informed consent.\n\nIBD without Depressive Disorder Group:\n\n1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).\n2. No history of depressive disorder diagnosis\n3. No previous use of antidepressant medications.\n4. Age ≥ 18 years.\n5. Willingness to participate and provision of written informed consent.\n\nControl Group:\n\n1. No history of inflammatory bowel disease, depressive disorder, or use of antidepressant medications.\n2. No gastrointestinal symptoms (e.g., diarrhea, constipation, abdominal pain) within the past 3 months, and no history of gastrointestinal diseases.\n3. Age ≥ 18 years.\n4. Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).\n2. Use of antibiotics or probiotic supplements within the past 6 months.\n3. Inability or difficulty in providing biological samples.\n4. Missing essential patient information.",{"count":441,"type":21},120,"Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited.\n\nThis study aims to investigate the diversity changes in the gut microbiome and metabolome of patients with comorbid IBD and depressive disorder through multi-omics approaches, to identify specific microbial and metabolic signatures associated with the comorbidity of these two conditions, and to provide a molecular basis for elucidating the underlying mechanisms.",[25,444],"Depressive Disorder",[25,444,446,447,448],"Comorbidity","Gut Microbiome","Metabolomics","2026-01-22",{"date":451,"type":36},"2026-01-23",{"date":453,"type":36},"2025-03-16",{"date":455,"type":21},"2027-11-30",{"name":457,"class":165},"Fang Tang",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":251,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":44},"100516202","pregnant-women-with-and-without-crohns-disease-to-explore-the-role-of-plastics-and-toxins-in-intestinal-inflammation-100516202","NCT06001450","Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation","PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation","PLANET","Inclusion Criteria:\n\n* The ability to sign and date an informed consent form\n* Be pregnant, or wishing to become pregnant in the near future and enroll the infant that the individual is pregnant with\n* Aged 18 or older\n* English-speaking (this observational study uses non-validated questionnaires that are only available in English)\n* Of any ethnicity\n* Be a spouse, related household member (sibling, parent, etc.) or a child of an enrolled pregnant person\n\nExclusion Criteria:\n\n* Individuals who are unable to give informed consent\n* Be diagnosed with a pregnancy complication, such as intrauterine fetal demise\u002Fstillbirth, preeclampsia, hyperemesis gravidarum, or have an active infection, including chorioamnionitis or sepsis.",{"count":467,"type":21},46,"The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and gut microbiome in order to understand the role of this pollutant on the risk of developing inflammatory bowel disease (IBD) as well as other diseases. With this information, the researchers hope to characterize better the role of environmental pollutants on IBD and develop novel strategies towards prevention.",[470,471,25],"Crohns Disease","Pregnancy",[473,474,475,476,477],"microplastics","nanoplastics","pregnancy","pollution","environmental pollutants","2026-01-06",{"date":480,"type":36},"2026-01-07",{"date":482,"type":36},"2023-08-15",{"date":484,"type":21},"2027-08-31",{"name":314,"class":165},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":251,"sex":16,"minAge":492,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":510,"locationsCount":44},"100401503","skeletal-health-and-bone-marrow-composition-in-newly-diagnosed-adolescents-with-crohn-disease-100401503","NCT04508088","Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease","Inclusion Criteria:\n\n* Crohn's Disease diagnosed within the past 3 months, or a healthy, matched control\n\nExclusion Criteria:\n\n* Participants with chronic disease known to affect skeletal metabolism\n* Participants on certain medications within the prior 3 months that are known to affect skeletal metabolism\n* Participants who are pregnant\n* Participants who have a history of: claustrophobia, internal body metal that is not compatible with MRI machine, or a known abnormality on or adjacent to the left knee","13 Years","20 Years",{"count":495,"type":21},92,"The investigators will be evaluating bone marrow composition via magnetic resonance imaging in newly diagnosed adolescents with Crohn disease (CD) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry and peripheral quantitative computed tomography. This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with newly diagnosed CD exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including bone turnover markers and immune cellular\u002Fmolecular parameters.",[25,72],[499,500,501,502,503],"Crohn","Bone Marrow","Dual-energy X-ray absorptiometry","Peripheral Quantitative Computed Tomography","Magnetic Resonance Imaging","2025-10-28",{"date":506,"type":36},"2025-10-30",{"date":508,"type":36},"2020-09-10",{"date":292,"type":21},{"name":511,"class":165},"Massachusetts General Hospital",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":101,"minAge":17,"maxAge":252,"enrollmentInfo":518,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":166},"100125752","a-multicenter-national-prospective-study-of-pregnancy-and-neonatal-outcomes-in-women-with-inflammatory-bowel-disease-100125752","NCT00904878","A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and\u002For biologic therapy\n\nExclusion Criteria:\n\n* Pregnant female patients younger than 18 years of age\n* Confirmed multiple gestation",{"count":411,"type":21},"A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.",[25],[522],"pregnant IBD patients","2025-07-02",{"date":525,"type":36},"2025-07-08",{"date":527,"type":4},"2007-08",{"date":529,"type":21},"2028-06",{"name":531,"class":165},"University of California, San Francisco",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":251,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":555},"100256265","characterization-of-phenotype-and-genotype-of-early-onset-enteropathies-100256265","NCT02614911","Characterization of Phenotype and Genotype of Early Onset Enteropathies","Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies","IMMUNOBIOTA","Main Inclusion Criteria:\n\n* Severe chronic enteropathy\n* Patients developing their first symptoms within the first 6 years of life and, in priority within the first two years of life, or patients with a disease of later onset, in case of a familial history suggestive of inherited mutations notably in families comprising several affected members\n* OR : Be a patient's relative, even if presenting with enteropathy of later onset.\n\nMain Exclusion Criteria:\n\n* Subject having participated to any therapeutical clinical study in the 30 days preceding the inclusion in this study,",{"count":541,"type":21},1445,"This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies.\n\nIn that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.",[25],[545],"Early Onset Entheropathy","2025-04-29",{"date":548,"type":36},"2025-04-30",{"date":550,"type":36},"2014-06-16",{"date":552,"type":21},"2054-06-15",{"name":554,"class":165},"Imagine Institute",12,{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":66,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":44},"100576171","research-on-the-use-of-probiotics-in-the-prevention-and-treatment-of-inflammatory-bowel-disease-100576171","NCT06781827","Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease","Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel","Inclusion Criteria:\n\n1. Be over 18 years old\n2. Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -\n\nExclusion Criteria:\n\n1. Does not meet the diagnostic criteria of CD\n2. Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc\n3. Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness\n4. Patients with suspected cancer in their intestines\n5. Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)\n6. There is currently an infection\n7. He has had cancer in the last 5 years -",{"count":130,"type":21},[153],"This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.",[25],"2025-03-31",{"date":569,"type":36},"2025-04-04",{"date":571,"type":36},"2025-01-01",{"date":573,"type":21},"2025-12-30",{"name":575,"class":119},"Wecare Probiotics Co., Ltd.",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":16,"minAge":583,"maxAge":584,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":44},"100387968","high-dose-interval-vitamin-d-supplementation-in-patients-with-inflammatory-bowel-disease-receiving-biologic-therapy-100387968","NCT04331639","High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy","Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab","Inclusion Criteria:\n\n* Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis\n* Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks\n* Age 5-25 years old, at study entry\n* Measured serum level of 25-OHD of less than 40 ng\u002FmL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD\n\nExclusion Criteria:\n\n* History of any underlying kidney disease\n* History of preexisting liver disease\n* History of granulomatous disease\n* Inability to take oral vitamin D3 as a pill\n* History of hypercalcemia or hypercalciuria\n* Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix","5 Years","25 Years",{"count":130,"type":21},"The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.",[25,72,27,588],"Vitamin D Deficiency","2025-02-27",{"date":591,"type":36},"2025-03-03",{"date":593,"type":36},"2020-11-01",{"date":595,"type":21},"2025-12-31",{"name":597,"class":165},"Boston Children's Hospital",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":66,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":4},"100574110","whey-protein-milk-derived-exosomes-100574110","NCT06755021","Whey Protein Milk-Derived Exosomes","Whey Protein Milk-Derived Exosomes Among Ulcerative Colitis Patients","Inclusion Criteria:\n\n* A confirmed clinical diagnosis of UC of any duration\n* Age 18-65 years\n* Signed informed consent\n* Presence of endoscopic evidence of colonic inflammation\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Milk allergy\n* Severe co-morbid medical illness such as uncontrolled diabetes, unstable cardiovascular or pulmonary disease, or malignancy\n* Specific exclusions: HIV , CMV , Hepatitis B or C, Abnormal AST or ALT at screening defined as \\> 3x upper limit of normal\n* Participating in another investigational drug study within 30 days of study enrollment\n* Evidence of colonic perforation\n* Massive hemorrhage from the colon requiring emergent surgery","65 Years",{"count":20,"type":21},[153],"This Phase 1B open-label, uncontrolled multicenter trial evaluates the safety, tolerability, and potential efficacy of WPMDE2, a whey protein milk-derived exosome supplement, in adult patients with mild to severe ulcerative colitis (UC). The study aims to explore clinical improvements in disease activity, quality of life, and inflammatory markers over an 8-week intervention period with a 2-week follow-up. WPMDE2 is administered orally in two dosage groups, with 100 participants stratified by disease severity. Key endpoints include changes in disease severity, fecal calprotectin levels, and patient-reported outcomes. Conducted under ethical guidelines, the study seeks to establish WPMDE2 as a safe, naturally derived adjunct therapy for UC patients.",[27,25],"2025-02-23",{"date":612,"type":36},"2025-02-25",{"date":614,"type":21},"2025-02-24",{"date":616,"type":21},"2026-04-01",{"name":618,"class":119},"Exosomm Ltd.",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":627,"targetDuration":629,"studyType":22,"phases":4,"briefSummary":630,"conditions":631,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100576084","efficacy-and-safety-of-upadacitinib-in-inflammatory-bowel-disease-100576084","NCT06780683","Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease","Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study","EaseUpIBD","Inclusion Criteria:\n\n* Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.\n\nExclusion Criteria:\n\n* Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.",{"count":628,"type":21},174,"1 Year","Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.",[25,26,27],"2025-01-13",{"date":634,"type":36},"2025-01-17",{"date":636,"type":36},"2024-01-01",{"date":638,"type":21},"2028-12-31",{"name":640,"class":165},"Xiang Gao",6]