[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibd-inflammatory-bowel-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibd-inflammatory-bowel-disease":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,46,81,107,126,158,184,207,229,260,284,308,330,353,380,406,430,455,489,513,540,563,585,608,637],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643044","individualizing-anti-tnf-therapy-in-patients-with-inflammatory-bowel-disease-100643044",false,"NCT07644117","Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease","Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease: Pre-Treatment Prediction of Immunogenicity and Response. A Prospective Observational Study.","Inclusion Criteria:\n\n* Established IBD: Crohn's disease (CD) or ulcerative colitis (UC)\n* Anti-TNF naïve\n* Clinically active disease (HBI\\>5 for CD, p-MS≥ 3 for UC)\n* Elevated inflammatory indices CRP\\>10 or fecal calprotectin\\>250\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Anti-TNF experienced\n* Unable to complete the study protocol","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","52 Weeks","OBSERVATIONAL","This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy.\n\nParticipants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.",[26,27,28],"IBD (Inflammatory Bowel Disease)","Crohn Disease (CD)","Ulcerative Colitis (UC)",[30,31,32],"IBD","Anti-TNF","Response to treatment","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-12","ACTUAL",{"date":39,"type":37},"2025-01-04",{"date":41,"type":21},"2028-12",{"name":43,"class":44},"Shmuel Kivity, MD","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":45},"100643065","phase-1-a-phase-i-study-to-evaluate-the-safetytolerability-of-bdhk-2009-tablets-in-healthy-adult-100643065","NCT07632573","A Phase I Study to Evaluate the Safety\u002FTolerability of BDHK-2009 Tablets in Healthy Adult","A Phase I Clinical Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics\u002FPharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose\u002FMultiple-dose Escalation Study.","Inclusion Criteria:\n\n\\- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.\n\n2\\. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg\u002Fm².\n\n4\\. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.\n\n5\\. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).\n\n1. WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;\n2. Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH \\> 40 mIU\u002FmL can confirm menopause.\n\n   6\\. Male participants with partners of childbearing potential are eligible for the study only if they agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product, and agree not to donate sperm during this period. In addition, male participants with partners of childbearing potential must use condoms continuously until at least 90 days after the last dose of the investigational product (whichever is longer).\n\n   Exclusion Criteria:\n   * 1\\. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.\n\n     2\\. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.\n\n     3\\. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.\n\n     4\\. History of recurrent or chronic infections.\n\n     5\\. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (\\>1 episode) herpes zoster or disseminated herpes zoster.\n\n     6\\. History of epidemic meningococcal infection.\n\n     7\\. History of splenectomy or functional asplenia.\n\n     8\\. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody.\n\n     9\\. Participants with a history of active tuberculosis or evidence of active or latent tuberculosis infection at screening.\n\n     10\\. Participants with a history of allergic tendencies, such as asthma, atopic dermatitis, chronic urticaria, or allergic rhinitis, or with allergies to two or more medications, foods, or pollens; participants with a history of hypersensitivity to the investigational drug or any of its components or to drugs with the same mechanism of action, or with clinically significant allergy history as determined by the investigator to be ineligible for enrollment.\n\n     11\\. Participants who have participated in another interventional clinical study and received an interventional treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first dose of the study drug, or within 5 half-lives of the study drug (whichever is longer).\n\n     12\\. Participants with a history of drug abuse within 12 months prior to screening, or participants with positive urine drug screening results.\n\n     13\\. Participants who have used any strong inducers or strong inhibitors of the hepatic metabolic enzyme CYP3A within 14 days or 5 half-lives prior to administration of the investigational drug (whichever is longer).\n\n     14\\. Participants who have used any prescription medications within 14 days prior to administration of the investigational drug, or any over-the-counter medications, herbal medicines, or dietary supplements within 7 days prior to administration of the investigational drug, unless the investigator determines that the medication is not clinically significant.\n\n     15\\. Participants who have consumed any foods or beverages containing substances that may induce or inhibit hepatic metabolic enzymes (such as grapefruit, Seville orange, or star fruit, etc.) within 7 days prior to administration of the investigational drug, or who are unable to avoid consumption of foods or beverages containing caffeine within 48 hours prior to administration of the investigational drug and throughout the inpatient study period.\n\n     16\\. Participants who consumed more than 14 units of alcohol per week within 1 month prior to screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or who consumed any alcohol products within 24 hours prior to dosing, or who have positive alcohol screening test results.\n\n     17\\. Heavy smokers or participants who smoked more than 5 cigarettes per day within 3 months prior to dosing, and who are unable to abstain from using more than 5 tobacco or nicotine-containing products (including nicotine patches) per week from screening through the end of the study.\n\n     18\\. Participants who donated blood or experienced blood loss ≥ 200 mL within 1 month prior to screening or dosing, or who donated blood or experienced blood loss ≥ 400 mL within 3 months prior to dosing, or who have difficult venous access or are unable to tolerate blood sampling.\n\n     19\\. At screening or baseline, 12-lead electrocardiogram (ECG) findings showing clinically significant abnormalities, including but not limited to: QTcF \\> 450 ms, or other arrhythmias or morphological abnormalities as determined by the investigator that may increase participant risk or interfere with data interpretation.\n\n     20\\. Participants with dysphagia or special dietary requirements who are unable to accept a standardized diet (e.g., severe food allergies).\n\n     21\\. Participants who have undergone major surgical procedures within 3 months prior to screening or who are planning to undergo surgery during the trial period.\n\n     22\\. Participants who have received vaccination within 8 weeks prior to screening, or who plan to receive vaccination during the study or within 8 weeks after administration of the study drug.\n\n     23\\. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.",true,"55 Years",{"count":56,"type":21},68,"INTERVENTIONAL",[59],"PHASE1","A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.",[28,62,63,26,64],"Ulcerative Colitis (Disorder)","Ulcerative Colitis Acute","CD - Crohn's Disease",[66,67,68,30,69,70],"Crohn's disease","Ulcerative Colitis","Inflammatory Bowel Disease","CD","UC","2026-06-02",{"date":73,"type":37},"2026-06-08",{"date":75,"type":37},"2026-05-18",{"date":77,"type":21},"2027-02-28",{"name":79,"class":80},"Benethera (Shaoxing) Biotechnology Co., Ltd.","INDUSTRY",{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100618752","analysis-of-factors-influencing-the-quality-of-bowel-preparation-before-colonoscopy-in-ibd-patients-100618752","NCT07335705","Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients","Analysis of Factors Influencing the Quality of Bowel Preparation Before Colonoscopy in IBD Patients: A National Multicenter Prospective Study","Inclusion Criteria:\n\n* Patients aged 18 years or older, of any gender, scheduled for colonoscopy;\n* Patients diagnosed with Inflammatory Bowel Disease (IBD) according to the 2023 edition of the Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;\n* Voluntary participation in this study and provision of signed informed consent.\n\nExclusion Criteria:\n\n* History of acute myocardial infarction (within the past 6 months), severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders;\n* Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders;\n* Pregnant or lactating women;\n* Acute intestinal infection within the past 2 weeks;\n* History of colorectal tumors, familial adenomatous polyposis, or Peutz-Jeghers syndrome;\n* History of intestinal obstruction, perforation, stenosis, or any other condition preventing completion of the examination;\n* Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the survey;\n* Individuals already enrolled in this study who schedule a repeat colonoscopy;\n* Currently participating in another clinical observational trial or having participated in any other clinical trial within the past 60 days;\n* Refusal to sign the written informed consent form.","75 Years",{"count":90,"type":21},1000,"The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.",[26,93,94],"Colonoscopy","Colonoscopy: Bowel Preparation",[30,93,96],"Bowel preparation","2026-05-12",{"date":99,"type":37},"2026-05-14",{"date":101,"type":37},"2025-12-08",{"date":103,"type":21},"2026-10-01",{"name":105,"class":106},"Changhai Hospital","OTHER",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":114,"targetDuration":4,"studyType":57,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":45},"100620148","pre-packaged-low-residue-diet-for-bowel-preparation-in-patients-with-inflammatory-bowel-disease-100620148","NCT07353853","Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease","Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial","Inclusion Criteria:\n\n* Age: Adult patients between 18 and 75 years old;\n* Diagnosis of IBD according to the 2023 Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;\n* Voluntary participation in this clinical trial and provision of signed informed consent.\n\nExclusion Criteria:\n\n* Patients with acute IBD, severe conditions, combined with major bleeding, suspected toxic megacolon, CD with severe intestinal stricture, gastrointestinal obstruction, or other conditions deemed unsuitable for colonoscopy by the physician;\n* Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction;\n* History of previous colorectal surgical resection or use of medications that may affect intestinal motility within one week (e.g., antidepressants, sedatives, calcium channel blockers);\n* History of stroke, spinal cord injury, or psychiatric disorders that impair compliance with bowel preparation and colonoscopy;\n* Allergy to any component of the administered drugs or meal replacements;\n* Pregnant or lactating women, and other individuals considered unsuitable for bowel preparation and colonoscopy by the physician.",{"count":90,"type":21},[116],"NA","The primary objectives of this project are twofold: firstly, to evaluate the role of Maifu Changqing® Complete Nutrition Formula Powder in bowel preparation for colonoscopy in patients with IBD; and secondly, to enhance the nutritional support and comfort of bowel preparation for IBD patients.",[26,93,94],[30,93,96],{"date":99,"type":37},{"date":122,"type":37},"2026-01-01",{"date":124,"type":21},"2026-06-30",{"name":105,"class":106},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":57,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":45},"100617129","combining-nutritional-therapy-and-anti-tnf-treatment-in-pediatric-patients-with-crohns-disease-100617129","NCT07314606","Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease","Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy","DISPENSE-T","Inclusion Criteria:\n\n* Moderate-severe active luminal inflammatory (B1) pCD \\[wPCDAI \\> or = 40\\] ileal +\u002F- colonic (L1, L2, L3), and in whom treating physician plans to start IFX\n* OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +\u002F- colonic (L1, L2, L3), and in whom treating physician plans to start IFX\n* Within 12-months of diagnosis (when starting IFX treatment)\n* Naïve to a biologic therapy\n* For patients with established disease who flare up: no response to dietary intervention or steroids within 4 weeks of commencement of these therapies.\n* For newly diagnosed patients: no response to dietary intervention or steroids within 2 weeks of commencement of these therapies.\n* Evidence of active inflammation: FCP level \\> 250 µg\u002Fg and\u002F or CRP \\> 5 mg\u002FL or ESR \\> 20 mm\u002Fhr\n* BMI between the 5th and 95th percentiles, adjusted for age and sex\n* On steroids or EEN for less than 2 (or 4, for established disease) weeks\n* Able and willing to follow dietary recommendations\n* On stable dose of AZA or Methotrexate (MTX) at randomization\n* Willing to enroll in the CIDsCaNN Network study\n\nExclusion Criteria:\n\n* CDED, EEN, or steroids commenced more than 2 weeks prior to randomization\n* Antibiotic use in the last 2 months (except short course \\\u003C 1 week between 1-2 months) or laxative use within the past month (except for bowel prep for endoscopy pre commencement of anti-TNFα)\n* Pre-, pro-, synbiotic supplements in the last month (food containing these products, e.g. yogurt, allowed)\n* Strict vegetarians and vegans\n* High risk of malnutrition as assessed by the Paediatric Yorkhill Malnutrition Score (PYMS)\n* Other known GI disorders (except IBS), food intolerances or chronic diseases\n* Bowel surgery prior the randomization\n* Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease\n* Currently on prednisone\u002Fprednisolone for \\> 2 weeks\n* Pregnant or breastfeeding\n* Participating in another study\n* Inability to consent","9 Years","17 Years",{"count":137,"type":21},140,[116],"Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.",[27,26,141],"IBD - Inflammatory Bowel Disease",[143,144,145,146,147,148],"CDED","Exclusion Diet","Infliximab","Nutritional therapy","Pediatric","Diet Intervention","2026-04-27",{"date":151,"type":37},"2026-05-01",{"date":153,"type":37},"2026-04-22",{"date":155,"type":21},"2029-10-01",{"name":157,"class":106},"University of British Columbia",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":53,"sex":166,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},"100622606","exploring-fecal-calprotectin-levels-maternal-and-infant-microbiota-infant-health-nutrition-and-adverse-pregnancy-outcomes-with-patient-with-inflammatory-bowel-disease-100622606","NCT07385807","Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease","Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)","CALINA-IBD","Inclusion Criteria:\n\nAll patients\n\n* Pregnant individuals ≥19 years recruited during their first, second or early third trimester.\n* Own or have regular access to a smartphone compatible with the study smartphone application RXFood.\n\nIBD patients\n\n● A documented IBD diagnosis (CD or UC) with active or quiescent disease.\n\nNon-IBD controls ● Absence of IBD.\n\nExclusion Criteria:\n\nAll patients\n\n* Inability to provide consent\n* Previous gastrointestinal cancer or bowel surgery\n* Renal disease\n* HIV\u002FAIDS or other serious infection\n* Fetal chromosomal or structural abnormalities\n* Other immune-mediated diseases (e.g., multiple sclerosis, rheumatoid arthritis, primary sclerosing cholangitis)\n* Prebiotic, probiotic or postbiotic supplements in the month prior to first sample collection\n* Gastroenteritis during or 1 month before the first sample collection\n* Travel outside of Canada and the United States in the month prior to first sample collection\n\nIBD patients\n\n● Pregnant individuals with active perianal or extra-intestinal disease in IBD","FEMALE","19 Years",{"count":169,"type":21},80,"The goal of this prospective longitudinal cohort study is to examine how the human microbiome of pregnant women-including bacteria and fungi in the gastrointestinal tract, vaginal canal, skin, and breastmilk-may influence infant gut inflammation, measured by fecal calprotectin (FCP) levels, and to identify factors that could inform dietary interventions to improve infant health outcomes. Specifically, the study aims to determine which maternal gut microbiome characteristics and dietary patterns during pregnancy are associated with elevated FCP levels in infants, and which infant gut microbiota compositions and dietary factors are linked to high FCP levels. Researchers will compare microbiome signatures and dietary factors in pregnant women and their infants with active or inactive IBD, as well as non-IBD controls, to identify microbial patterns that may predict infant gut inflammation. Participants will provide fecal samples at all study timepoints, one vaginal swab during the third trimester of pregnancy, and optional breastmilk and breast skin swab samples. They will also complete 3-day diet recalls using a smartphone app and participate in a longitudinal follow-up over 12 months after birth to monitor dietary patterns, microbiome profiles, and gut inflammation in both mother and infant.",[26,30,141,172],"Pregnancy",[172,30,174,67,164,68],"Crohn's Disease","2026-04-03",{"date":177,"type":37},"2026-04-06",{"date":179,"type":37},"2026-03-20",{"date":181,"type":21},"2028-02-01",{"name":157,"class":106},2,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":192,"maxAge":18,"enrollmentInfo":193,"targetDuration":4,"studyType":57,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":45},"100629119","mici-bio-study-on-patient-with-chronic-inflammatory-bowel-disease-100629119","NCT07470502","MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease","Single-center Pilot Study for Proactive Monitoring of Infliximab in Patients With Chronic Inflammatory Bowel Disease Starting Biologic Therapy: Comparative Assessment of Plasma and Salivary Levels","MICI-BIO","Inclusion Criteria:\n\n* Age between 3 and 18 years\n* diagnosis of Crohn's disease or ulcerative colitis\n* starting biological therapy with infliximab;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients in whom the diagnosis of IBD has not been confirmed according to standardized endoscopic and histological criteria;\n* Patients who refuse to participate in the study.","3 Years",{"count":194,"type":21},15,[116],"This is a monocentric, non-profit prospective cohort study with longitudinal biological sampling. The study will include patients with IBD starting biological therapy with infliximab. During four routine clinical visits in the induction phase (standard or accelerated) and the first maintenance visit, two saliva samples (pre- and post-infusion) and one plasma sample (pre-infusion) will be collected. Plasma samples will be obtained from leftover blood collected during routine clinical practice, with no additional blood draws required. The induction regimen (standard or accelerated) will be determined by the treating physicians based on the patient's clinical and laboratory characteristics and will not be influenced by study participation. The study focuses on the first four infliximab infusions (three induction and one maintenance). Standard induction lasts 14 weeks (infusions at weeks 0, 2, 6, and 14), while accelerated induction lasts 8 weeks (infusions at weeks 0, 1, 4, and 8).\n\nThe primary objective of the study is to compare infliximab levels measured in plasma with infliximab levels in saliva in a sample of 15 patients receiving the drug during the first four infusions after a diagnosis of IBD. The study is purely exploratory, and the collected data will not be used for diagnostic or therapeutic purposes.",[26],"2026-03-10",{"date":200,"type":37},"2026-03-13",{"date":202,"type":37},"2025-02-13",{"date":204,"type":21},"2028-08-13",{"name":206,"class":106},"Meyer Children's Hospital IRCCS",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":214,"targetDuration":4,"studyType":57,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":45},"100621656","phase-1-a-phase-i-study-of-hw201877-in-healthy-subjects-100621656","NCT07373457","A Phase I Study of HW201877 in Healthy Subjects","A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK\u002FPD, Food Effect of HW201877 in Healthy Volunteers.","Key Inclusion Criteria:\n\n* Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions.\n* Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration.\n* 18 years to 55 years (inclusive), male and female.\n* Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg\u002Fm2 (inclusive) .\n\nKey Exclusion Criteria:\n\n* Smoking more than 5 cigarettes per day within 3 months prior to screening.\n* Allergic diathesis (with a history of allergies to multiple drugs and foods).\n* A history of drug abuse and\u002For alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine).\n* Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening.\n* Have consumed special diets (including pitaya, mango, lime, grapefruit, carambola, orange, grapefruit or grapefruit-containing products, etc.) or engaged in strenuous exercise within 2 weeks prior to screening, or having other factors that may affect the absorption, distribution, metabolism and excretion of the study drug.\n* Have taken any investigational drugs or participated in any other clinical drug trials within 3 months prior to the first administration of the study drug.\n* Clinically significant abnormalities in clinical laboratory tests, or a history of clinically significant findings of the following diseases within 12 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardio-cerebrovascular diseases).\n* Unable to tolerate venipuncture, or with a history of needle phobia or hematophobia.\n* Not suitable for this study as judged by the investigator.",{"count":215,"type":21},104,[59],"This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).",[219,26],"Healthy Participants","2026-01-19",{"date":222,"type":37},"2026-01-28",{"date":224,"type":37},"2025-06-26",{"date":226,"type":21},"2026-03",{"name":228,"class":80},"Wuhan Humanwell Innovative Drug Research and Development Center Limited Company",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":238,"studyType":23,"phases":4,"briefSummary":239,"conditions":240,"keywords":243,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":45},"100611407","optimization-of-inflammatory-bowel-disease-treatment-through-understanding-of-gut-virome-heterogeneity-100611407","NCT07240181","OPTImization of Inflammatory Bowel Disease Treatment Through Understanding of Gut VIRome Heterogeneity","Optimization of Inflammatory Bowel Disease Treatment Through Understanding of Gut Virome Heterogeneity and the Potential for Bacteriophage-based Therapy","OPTIVIR","Inclusion criteria for patients:\n\n* Confirmed diagnosis of UC, CD, or PSC-IBD for at least 6 months\n* Age ≥ 18 years\n* Stable medical treatment for IBD (and PSC-IBD) within the past 3 months\n* Stable lifestyle within the past month (including diet, exercise, and sleep habits)\n* Verbal and written informed consent\n\nExclusion criteria for patients:\n\n* Use of antibiotics within the past 3 months\n* Pregnancy or breastfeeding\n* Substance abuse or excessive alcohol consumption (according to Danish Health Authority guidelines)\n* Other known comorbidities that may affect the gut microbiome (e.g., type 1 diabetes, other autoimmune diseases, cancer, severe obesity, etc.)",{"count":20,"type":21},"1 Month","Title: The Role of Good Viruses in Inflammatory Bowel Disease\n\nBackground An imbalance in the bacteria in the gut - called gut dysbiosis - is linked to chronic bowel diseases such as Crohn's disease and ulcerative colitis (IBD). A special and more severe form of IBD, called primary sclerosing cholangitis-associated IBD (PSC-IBD), affects both the gut and the bile ducts, and in serious cases can lead to liver failure. There is currently no cure for IBD.\n\nResearch suggests that microorganisms in the gut, especially bacteria and viruses called bacteriophages, play an important role in how the disease develops. Treatment with stool from healthy donors, known as fecal microbiota transplantation (FMT), has proven effective against certain infections and has shown promising results in IBD. A newer and possibly safer method is fecal virome transplantation (FVT), where only the virus part (the gut virome) of the stool is used.\n\nBacteriophages can kill harmful bacteria and help restore balance in the gut, but their use is still experimental. Therefore, we aim to develop a new treatment by growing bacteriophages from healthy individuals in the lab and using them to restore a healthy balance of bacteria and viruses in the gut of patients with IBD.\n\nPurpose of the study The long-term goal of the study is to improve treatment for IBD by gaining a better understanding of differences in the gut virome between IBD patients and healthy people. We also want to explore whether \"fermented\" bacteriophages from donor stool can be developed into a future bacteriophage-based therapy.\n\nThis will be studied using experimental lab setups and animal models. The study will include 10 healthy stool donors and 30 IBD patients (10 with ulcerative colitis, 10 with Crohn's disease, and 10 with PSC-IBD). The study does not involve any treatments - only the collection of biological samples and access to information about your health from your medical record.",[26,241,242],"Crohns Disease","Colitis Ulcerative",[244,245,246,247,248,249],"Bacteriophages","Gut virome","Bacteriophage therapy","Fecal virome transplantation","Fecal filtrate transplantation","Gut microbiome imbalances","NOT_YET_RECRUITING","2025-11-19",{"date":253,"type":37},"2025-11-20",{"date":255,"type":21},"2025-12-01",{"date":257,"type":21},"2029-12-31",{"name":259,"class":106},"Andreas Munk Petersen",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":267,"maxAge":135,"enrollmentInfo":268,"targetDuration":4,"studyType":57,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":45},"100607943","evaluation-of-the-smart-ibd-app-in-pediatric-ibd-100607943","NCT07195123","Evaluation of the SMART IBD App in Pediatric IBD","Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)\n* Prescribed at least one daily or weekly medication for treatment of IBD\n* \\\u003C86% adherence to prescribed medication\n* Access to internet via Wi-Fi or data plan and access to smartphone\n* English fluency for patient and caregiver\n\nExclusion Criteria:\n\n* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review","13 Years",{"count":269,"type":21},70,[116],"The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.",[273,26,141,28,274,27,30],"Inflammatory Bowel Disease (IBD)","Indeterminate Colitis",[30,68,67,274,241],{"date":277,"type":37},"2025-11-21",{"date":279,"type":37},"2025-10-23",{"date":281,"type":21},"2027-08-31",{"name":283,"class":106},"Children's Hospital Medical Center, Cincinnati",{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":291,"maxAge":18,"enrollmentInfo":292,"targetDuration":291,"studyType":23,"phases":4,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100612008","neurological-manifestations-in-children-diagnosed-with-inflammatory-bowel-disease-100612008","NCT07247994","Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease","Neurological Manifestations in Children Diagnosed With Inflammatory Bowel Disease in Assiut University Child Hospital","Inclusion Criteria:\n\n* patients with IBD aged from from 1 to18 years old.\n\nExclusion Criteria:\n\n* patients with IBD and aged above 18 years old or below 1 year old","1 Year",{"count":293,"type":21},44,"screen for neurologic and psychiatric disorders in children and\n\nadolescents with IBD.",[26],[297,298,299],"Extraintestinal manifestations","Inflammatory bowel disease","Ibd","2025-11-18",{"date":302,"type":37},"2025-11-25",{"date":122,"type":21},{"date":305,"type":21},"2027-03-01",{"name":307,"class":106},"Bishoy Shehata Fahim",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":57,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":45},"100605897","diet-and-stress-management-combined-with-advanced-therapy-for-crohns-and-ulcerative-colitis-100605897","NCT07168499","Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis","D-SCAPE - Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis - A Pragmatic Clinical Trial","D-SCAPE","Inclusion Criteria:\n\n1. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.\n2. At least 18 years of age\n3. Established diagnosis of CD, UC, or IBD-unspecified\n4. Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)\n5. Initiating advanced therapy (anti-TNF agents, anti-integrin agents, anti-IL12\u002F23, anti-IL23 agents, S1P receptor modulators, JAK inhibitors) for IBD per usual clinical care within 2 weeks of baseline\u002Frandomization, regardless of prior exposure to advanced therapies or disease duration\n6. Other non-biologic IBD medications must remain stable during the treatment period and no medication changes are planned with the exception of tapering of corticosteroids.\n7. Current disease activity defined as a Harvey Bradshaw index \\> 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index \\> 2 at baseline (week 0) for UC subjects or having had a recent exacerbation being treated with systemic steroids or budesonide.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.\n2. Initiation of advanced therapy for extra-intestinal symptoms alone\n3. Known eating disorders\n4. Already receiving dietary therapy or stress management interventions\n5. Severe untreated psychiatric comorbidity including history of suicidal thoughts\n6. Evidence of untreated infection (e.g. Clostridium difficile)\n7. Presence of stoma or J-pouch\n8. Female subjects who are pregnant, lactating, or intending to become pregnant during the study period\n9. On total parental nutrition (TPN) or already following a therapeutic diet for IBD.",{"count":317,"type":21},160,[116],"Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness\u002Fstress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC.\n\nResearchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores.\n\nGroups:\n\n1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+\u002F-2 weeks after the first intervention visit.\n2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+\u002F-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes).\n3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+\u002F-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes).\n4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes).\n\nAll subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.",[26],"2025-11-05",{"date":323,"type":37},"2025-11-06",{"date":325,"type":37},"2025-09-15",{"date":327,"type":21},"2028-05-01",{"name":329,"class":106},"Massachusetts General Hospital",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":4},"100608745","utilization-of-musculoskeletal-ultrasound-to-detect-subclinical-findings-in-ibd-patients-100608745","NCT07205549","Utilization of Musculoskeletal Ultrasound to Detect Subclinical Findings in IBD Patients","Role of Musculoskeletal Ultrasound in Detection of Subclinical Findings in Inflammatory Bowel Disease Patients","Inclusion Criteria:\n\n* patients diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Patients without a definite diagnosis of inflammatory arthritis, to focus on subclinical musculoskeletal involvement.\n\nExclusion Criteria:\n\n* Patients with a prior clinical diagnosis of inflammatory arthritis or other rheumatologic diseases.\n* Patients with complicated or severe comorbidities that may interfere with musculoskeletal evaluation or study participation (e.g., severe infections, malignancies).",{"count":338,"type":21},81,"Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, frequently presents with musculoskeletal extraintestinal manifestations (EIMs), such as arthritis and enthesitis, affecting up to 50% of patients. These can be subclinical and are often underestimated by physical examination alone. Musculoskeletal ultrasound (MSK-US) is a sensitive, non-invasive tool for detecting both clinical and subclinical inflammation. Despite its benefits, there is no standardized MSK-US protocol specifically for IBD patients. This study aims to develop a structured MSK-US assessment protocol, evaluate its effectiveness in detecting musculoskeletal involvement, and investigate its relationship with IBD disease activity.",[26,341],"Musculoskeletal Ultrasound",[30,343],"MSK_US","2025-09-25",{"date":346,"type":37},"2025-10-03",{"date":348,"type":21},"2025-10-01",{"date":350,"type":21},"2025-12-30",{"name":352,"class":106},"Assiut University",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":57,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":45},"100606561","phase-1-the-prospective-improved-vitamin-d-study-for-inflammatory-bowel-disease-patients-100606561","NCT07177157","The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients","The Prospective Improved Vitamin D Study for IBD Patients Part 2 (The PIVD Study Part 2)","PIVD","Inclusion Criteria:\n\n1. Adults Aged 18-85\n2. Diagnosis of IBD (Ulcerative Colitis or Crohn's Disease) within the patient's records based on standard clinical, endoscopic, and radiologic criteria.\n3. Patients within outpatient gastroenterology clinics at Victoria Hospital and St. Joseph's Hospital with follow-up appointments within the next 2 years (ongoing IBD care).\n4. Participants must have the ability to read, comprehend, and voluntarily provide informed consent without assistance.\n\nExclusion Criteria:\n\n1. Those who do not meet the inclusion criteria.\n2. Those with any concurrent diagnosis of disease that may affect calcium or Vitamin D metabolism (i.e., rheumatoid arthritis or other inflammatory joint disease, thyroid disease, parathyroid disease, primary bone disease, granulomatous disease, sarcoidosis, lymphoma).\n3. Those with either renal dysfunction (serum creatinine \\>0.150 mmol\u002FL) or receiving dialysis were excluded, patients with chronic liver disease, and hypercalcemia (\\>2.65mmol\u002FL).\n4. Those using oral corticosteroids for the management of any disease other than IBD.\n5. Those with a history of Vitamin D or calcium supplementation within 6 months prior to the trial.\n6. Those who were seen once by the gastroenterology team but never followed up (no ongoing IBD care).","85 Years",{"count":363,"type":21},150,[59],"The aim of this clinical trial is to gain a better understanding of the effect of Vitamin D supplementation on disease activity and overall health. The main questions it aims to answer are:\n\n1. What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period?\n2. Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients?\n3. Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period?\n4. Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period?\n5. Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients?\n6. Is 2,000 IU\u002FDay an effective dose to sustain appropriate blood Vitamin D levels among previously Vitamin deficient IBD patients?\n\nParticipants will:\n\n* Take 2000 IU of Vitamin D every day for the next 12 months\n* Complete 2 surveys, bloodwork and a fecal calprotectin test at the initial, visit, 6 month follow up and 12 month follow up",[28,26,27],[368,68,30,67,369,370,27],"vitamin D","Bone Health","Immune Modulation","2025-09-12",{"date":373,"type":37},"2025-09-16",{"date":375,"type":21},"2025-10",{"date":377,"type":21},"2027-03",{"name":379,"class":106},"Terry Ponich",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":57,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100606237","research-and-follow-up-of-the-determinants-of-the-progression-and-complications-of-inflammatory-bowel-diseases-treated-or-not-with-immunosuppressants-100606237","NCT07172945","Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.","Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants","SUIVITHEQUE2","Inclusion Criteria:\n\nFor all patients and control subjects\n\n* Person able to give free and informed consent.\n* Age ≥ 18 years.\n* Beneficiary of a social protection scheme or entitled person (excluding AME).\n* Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital\n\nPatients with IBD :\n\n\\- Patients with Crohn's disease or haemorrhagic rectocolitis with a diagnosis established or confirmed in the Gastroenterology and Nutrition Department at Saint-Antoine Hospital.\n\nMicrobiota control' subjects:\n\n\\- Healthy subjects seen in consultation as a preventive measure or as part of stool donations for FMT.\n\nEndoscopy control' subjects:\n\n\\- Subjects with a medical indication for digestive endoscopy with biopsies:\n\n* For upper endoscopy: moderate upper digestive symptoms such as epigastralgia or pyrosis\n* For colonoscopy: moderate digestive symptoms suggestive of irritable bowel syndrome or screening for colorectal cancer.\n\nExclusion Criteria:\n\nFor all patients and control subjects\n\n* Subjects under guardianship, curatorship or safeguard of justice.\n* Subjects who do not speak French.\n\nIBD patients:\n\n\\- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).\n\nEndoscopy control' and \"microbiota control\" subjects:\n\n* Subject suffering from a chronic disease\n* Antibiotics taken in the 6 weeks prior to endoscopy\n* Antibiotics or colonic preparation taken within 6 weeks prior to stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).",{"count":389,"type":21},4500,[116],"Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options.\n\nThe exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression.\n\nDue to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.",[393,28,26],"Crohn",[395,396,393,397,30],"Microbiome","Biobank","Ulcerative colitis","2025-09-08",{"date":325,"type":37},{"date":401,"type":21},"2025-09",{"date":403,"type":21},"2040-11",{"name":405,"class":106},"Assistance Publique - Hôpitaux de Paris",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":57,"phases":415,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":426,"leadSponsor":428,"locationsCount":45},"100605344","phase-4-remimazolam-for-colonoscopy-in-ibd-patients-100605344","NCT07161297","Remimazolam for Colonoscopy in IBD Patients","* Inclusion Criteria\n\n  * Age ≥18 years\n  * Diagnosis of IBD (CD or UC) for ≥6 months\n  * Scheduled colonoscopy for clinical or surveillance purposes\n  * Ability to provide informed consent\n* Exclusion Criteria\n\n  * ASA class IV\n  * Allergy to benzodiazepines, opioids, flumazenil, or naloxone\n  * Severe COPD\n  * Obstructive sleep apnea\n  * BMI \\>35\n  * Pregnancy or lactation\n  * Prior multiple ileocolonic resections or subtotal colectomy\n  * Inability to complete questionnaires","90 Years",{"count":414,"type":21},200,[416],"PHASE4","The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.\n\nThe main questions it aims to answer are:\n\n* Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy?\n* Does remimazolam allow faster recovery and discharge readiness compared to midazolam?\n\nResearchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.\n\nParticipants will:\n\n* Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy\n* Complete a short questionnaire to rate their satisfaction after the procedure\n* Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure",[26],[420,421,422],"Inflammatory bowel disease (IBD)","Remimazolam","Midazolam","2025-09-01",{"date":398,"type":37},{"date":423,"type":21},{"date":427,"type":21},"2025-09-30",{"name":429,"class":106},"Humanitas Clinical and Research Center",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":57,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":453,"locationsCount":183},"100602316","ex-vivo-confocal-imaging-and-proteomic-profiling-to-determine-treatment-response-in-children-with-ibd-100602316","NCT07121920","Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD","A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease","Inclusion Criteria:\n\n\\- Patients must fall into one of the below categories: (i) with suspected and\u002For established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls\n\nExclusion Criteria:\n\n* Those with previous allergy to fluorescein\n* Pregnant and breastfeeding patients","2 Years","21 Years",{"count":20,"type":21},[116],"This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of\u002Fstrongly correlated to clinical response\u002Foutcomes observed.\n\nThe key questions under investigation are:\n\nAim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy).\n\nAim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.\n\nAim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.",[26,30,141],[444,298,30,445,446],"Ex-vivo","CLE","Confocal laser endomicroscopy","2025-08-12",{"date":449,"type":37},"2025-08-14",{"date":423,"type":21},{"date":452,"type":21},"2028-07-01",{"name":454,"class":106},"Cook Children's Health Care System",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":57,"phases":464,"briefSummary":465,"conditions":466,"keywords":472,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":183},"100586637","study-of-treatment-with-intensified-omeprazole-treatment-to-prevent-high-output-stoma-1-100586637","NCT06917963","Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1","Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial","STOP-HOS-1","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled for elective or emergency surgery requiring end or loop ileostomy formation\n* Able and willing to provide written informed consent\n* No contraindications to omeprazole use\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)\n* Conditions preventing accurate measurement of daily ileostomy output",{"count":169,"type":21},[116],"The goal of this clinical trial is to evaluate if intensified omeprazole therapy can reduce high-output stoma (HOS) in adults undergoing ileostomy formation surgery. The main objectives of the study are:\n\n* To assess if intensified omeprazole treatment significantly reduces mean daily ileostomy output (ml\u002F24h) during the first three postoperative days compared to standard omeprazole treatment.\n* To evaluate the proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml\u002Fday) on consecutive postoperative days.\n* To measure the time required for stabilization of ileostomy output (\\\u003C1400 ml\u002Fday maintained for three consecutive days).\n* To determine the incidence of dehydration-related complications, specifically electrolyte disturbances (hyponatremia, hypokalemia).\n* To compare the length of initial hospital stay, frequency of rehospitalizations within 30 days post-discharge, and total length of hospital stay (including rehospitalizations).\n\nResearchers will compare 10 days intensified omeprazole treatment (loading dose of 80 mg IV followed by 40 mg IV twice daily) with standard treatment (40 mg IV once daily) to determine the effectiveness of intensified dosing in reducing ileostomy output and improving postoperative outcomes.\n\nParticipants will:\n\n* Receive either standard or intensified intravenous omeprazole during their hospitalization and after discharge for 10 days combined.\n* Undergo daily measurements of ileostomy output.\n* Have routine laboratory assessments of electrolyte levels.\n* Participate in follow-up assessments up to 30 days post-discharge, conducted either through outpatient visits or telephone consultations.",[467,468,469,26,470,471],"Stoma - Ileostomy","High Output Stoma","Colon Cancer","Ileus","Omeprazole",[473,474,475,476,477,478,479],"stoma","ileostomy","high output stoma","omeprazole","ipp","colon cancer","ibd","2025-07-28",{"date":482,"type":37},"2025-07-31",{"date":484,"type":37},"2025-04-10",{"date":486,"type":21},"2027-07",{"name":488,"class":106},"Medical University of Gdansk",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":496,"targetDuration":4,"studyType":57,"phases":498,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":45},"100596582","phase-2-evaluate-the-efficacy-and-safety-of-probiotic-6600-as-an-adjuvant-therapy-for-colitis-100596582","NCT07047339","Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis","Inclusion Criteria:\n\n1. Ulcerative colitis (UC) : met the clinical diagnostic criteria of UC \"Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi 'an)\", and modified Mayo score ≥4 points;\n2. Crohn's disease (CD) : met the clinical diagnostic criteria of CD \"Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)\", and CDAI score ≥220;\n3. Colitis: clinical diagnosis of colitis and modified SCCAI score ≥3; 3.\n4. The age of signing the informed consent form was from 18 to 75 years old (including the cut-off value, male and female were not limited);\n5. Complete medical history;\n6. From the time of informed consent until 3 months after the last dose of dose, the participant committed to not having any plans to have children or to have any plans to donate sperm or eggs, and to voluntarily use non-pharmacologic contraception;\n7. Fully understand the content, process and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Taking prebiotics or probiotics in the past 2 weeks or allergic to intervention preparations;\n2. Short bowel syndrome, abdominal abscess, toxic megacolon, intestinal perforation, active fistula of digestive tract, severe intestinal stenosis with obstructive symptoms, suspected intestinal obstruction, total colectomy;\n3. Other autoimmune diseases, hematological diseases, tumors, acute infections, severe hepatic and renal insufficiency (ALT\\>2 times the upper limit of normal), severe diseases such as neutropenia, heart failure, organic heart disease, viral hepatitis B, liver cirrhosis, renal impairment (serum creatinine \\> 2mg\u002FdL or 177mmol\u002FL), AIDS And mental disorders;\n4. History of psychoactive substance abuse;\n5. A history of drug or other dependent substance abuse, or heavy alcohol consumption in the last 2 weeks (i.e. 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14g of alcohol, such as 360mL of beer or 25mL of 40% spirits or 150mL of wine); Heavy drinkers during the trial;\n6. Pregnant or breastfeeding women, or planning to become pregnant in the next 6 months;\n7. Nervous system diseases such as Alzheimer's disease, stroke, Parkinson's disease;\n8. Participated in other clinical trials within the past 6 months;\n9. Incomplete medical record information (including gender, age, diagnostic information, colonoscopy results, pathological diagnosis results and other demographic data, etc.);\n10. Other investigators deemed ineligible for enrollment.",{"count":497,"type":21},120,[499,500],"PHASE2","PHASE3","This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore \\>1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore \\>1; CDAI score ≤2 and no single subscore \\>1) were used as the primary efficacy index.",[503,26,504],"Colitis","Probiotic Intervention","2025-06-24",{"date":507,"type":37},"2025-07-02",{"date":509,"type":21},"2025-07-01",{"date":511,"type":21},"2026-12-31",{"name":105,"class":106},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":57,"phases":523,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":539},"100575507","assessing-interventions-of-diet-in-ibd-100575507","NCT06773182","Assessing Interventions of Diet in IBD","Understanding Patient's Barriers and Perceived Benefits Through Adherence to Nutritional Interventions in IBD: a Preliminary Study.","AID-IBD","Inclusion Criteria:\n\n* Adults (18+ years) diagnosed with ulcerative colitis or Crohn's disease.\n* Having willingness to use their personal smartphone to access the app\n* Able to understand the indication by the registered dietitian.\n* Able to provide informed consent.\n* Willingness to attempt intervention diet and commit to study procedures.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Currently being treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders.\n* Currently being treated for chemotherapy.\n* Diabetes\n* Advance chronic kidney disease\n* Short bowl syndrome",{"count":522,"type":21},45,[116],"In this study, we are trying to learn how certain diets affect people with inflammatory bowel disease (IBD). We want to understand what makes it hard or easy for them to stick to different eating plans, like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet. By finding out how these diets help with symptoms and which ones are easier to follow, we hope to improve the quality of life for people with IBD.",[26,28,27],[30,527,528,529,397,530],"Low FODMAP Diet","Mediterranean diet","Intermittent fasting","Crohn's disease","2025-06-23",{"date":224,"type":37},{"date":534,"type":37},"2025-04-01",{"date":536,"type":21},"2027-01-01",{"name":538,"class":106},"McMaster University",3,{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":45},"100590430","human-and-microbial-determinants-of-the-onset-of-ibd-flares-100590430","NCT06967311","Human and Microbial Determinants of the Onset of IBD Flares","Microbial and Human Determinants of the Onset of IBD Flares","Inclusion Criteria:\n\n* Patient at Universidade Federal de Santa Catarina (UFSC) Hospital, under care of Dr. Vivian Menegassi\n\nExclusion Criteria:\n\n* Cancer Diagnosis\u002FTreatment\n* Under 18 years old",{"count":548,"type":21},100,"This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.",[26],[552,30,553],"observational","microbiome","2025-06-12",{"date":556,"type":37},"2025-06-15",{"date":558,"type":37},"2025-01-31",{"date":560,"type":21},"2030-02",{"name":562,"class":80},"Viome",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":53,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":57,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100590017","enhancing-endoscopic-scoring-consistency-and-accuracy-in-ibd-a-video-based-training-approach-100590017","NCT06961942","Enhancing Endoscopic Scoring Consistency and Accuracy in IBD: a Video-based Training Approach","CONCORDIA","Inclusion Criteria:\n\n* Gastroenterology fellows\n\nExclusion Criteria:\n\n* NA",{"count":20,"type":21},[116],"Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes.\n\nOne of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency.\n\nInconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems.\n\nThe primary objective of this study is to evaluate the improvement of scoring accuracy after training with structured educational videos with a specific focus on the learning curve and the practical application of endoscopic scoring systems.",[26],[575,576,30],"Training","Scoring","2025-05-05",{"date":579,"type":37},"2025-05-08",{"date":427,"type":21},{"date":582,"type":21},"2026-12-30",{"name":584,"class":106},"Universitaire Ziekenhuizen KU Leuven",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":591,"enrollmentInfo":592,"targetDuration":4,"studyType":57,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":45},"100586597","abdominally-targeted-management-exercises-for-crohns-disease-patients-tame-cd-100586597","NCT06917443","Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)","Inclusion Criteria:\n\n* Patients with no treatment or on constant medicinal therapy, expected to remain constant: mesalamine for at least 6 weeks, steroids at least 2 weeks (≤20mg prednisone or budesonide ≤6mg), immunomodulatory at least 12 weeks or biologics\u002F small molecules for at least 12 weeks therapy. Patients who initiate the study on steroids will remain on a constant dose throughout the study.\n* If patients stopped therapy prior to the study then they should be at least 2 weeks from stopping steroids or 5ASA, or 4 weeks from stopping small molecules, 8 weeks from stopping biologics, or 12 weeks from stopping thiopurines.\n* CD patients will be included if their symptoms score \\>4 and ≤15 on the HBI score\n* Fecal calprotectin\\>150ug\u002Fgr or evidence of an active disease per IUS defined as increased blood flow (modified Limberg score\\>0) or thickness of bowel wall\\>3mm\n\nExclusion Criteria:\n\n* Inability to commit for performing at least 10-15 minutes of exercise, 6 times a week.\n* Lack of availability or capability to use a computer\u002F internet.\n* Any proven current infection such as, fever, active abscess, Clostridioides difficile infection, positive stool culture, or parasite in patients with chronic diarrhea.\n* Inability to sign informed consent and\u002F or complete the study protocol.\n* Incompetent individuals who are unable to provide informed consent.\n* Planed pregnancy or pregnancy- up to 3 months post labor.\n* Subjects with chronic conditions such as active arthritis, cancer (within the previous 5 years, not including BCC, SCC), organ transplant subjects, advanced kidney or liver disease, or systemic inflammatory conditions other than IBD.\n* Patients who underwent surgery in the previous 3 months, had more than 1 surgery of intestinal resection, patients with ileostomy, pouch or patients with short bowel (small intestine\\\u003C1.5 meter).\n* Patients with a significant abdominal wall hernia, unless received a written confirmation from a treating surgeon.\n* Active peri-anal disease (fistula, abscess, fissure), stricturing or penetrating disease\n* Active extra-intestinal manifestations (not excluded are- oral aphthae and peripheral arthralgia without arthritis)\n* Patients on total parenteral nutrition (TPN) or on exclusive enteral nutrition (EEN).\n* Probiotics or antibiotics in the 15 days prior to enrollment or during the study period.","60 Years",{"count":593,"type":21},42,[116],"The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients.\n\nThe main questions it aims to answer are:\n\nDoes abdominally targeted exercises can improve the quality of life of CD patients.\n\nDoes abdominally targeted exercises positively influence clinical and biological responses in CD patients.\n\nResearchers will compare performing sets of special physical exercises designed for CD patients, compared to a control set of exercises (\"generic\" physical activity) to see if exercises designed for CD can result in an improved quality of life, in CD patients suffering from mild to moderate disease activity.\n\nParticipants will:\n\n* Perform physical exercises designed for CD or control set of exercises every day for 8 weeks.\n* Visit the clinic once every 4 weeks for doctor visit, blood and stool test and filling out questionnaires.",[27,26],[598,530,599],"physical exercise","randomized trial","2025-03-31",{"date":602,"type":37},"2025-04-08",{"date":604,"type":21},"2025-04",{"date":606,"type":21},"2029-08",{"name":43,"class":44},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":615,"targetDuration":617,"studyType":23,"phases":4,"briefSummary":618,"conditions":619,"keywords":624,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":4},"100565179","hemorrhoidal-disease-in-inflammatory-bowel-disease-a-multicenter-prospective-cohort-study-100565179","NCT06638814","HEmorrhoidAl Disease in Inflammatory Bowel Disease: a Multicenter Prospective Cohort Study","HEAD-IBD-II","Inclusion Criteria:\n\n* age of 18 years and above;\n* established diagnosis of Crohn's disease or ulcerative colitis at the time of surgery for hemorrhoidal disease;\n* planned surgery for hemorrhoidal disease during the study period, including hemorrhoidectomy (open, close or submucosal), transanal hemorrhoidal dearterialization, hemorrhoidal laser procedure, stapled hemorrhoidopexy).\n\nExclusion Criteria:\n\n* previous surgery for hemorrhoidal disease other than office-based treatments (e.g., sclerotherapy injection, rubber band ligation);\n* active perianal disease at the time of surgical intervention.",{"count":616,"type":21},50,"12 Months","Patients who will undergo surgery for HD after the diagnosis of IBD over a 12-month period will be enrolled across Europe.\n\nPrimary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients.\n\nSecondary aim is to identify factors that may affect clinical and surgical outcomes.",[26,620,621,622,623],"Hemorrhoid","Safety","Sugery","Surgery Related Complications Rate",[613,625,30,626],"Hemorrhoidal disease","Surgery","2024-10-10",{"date":629,"type":37},"2024-10-15",{"date":631,"type":21},"2025-01-01",{"date":633,"type":21},"2027-01-31",{"name":635,"class":636},"Treviso Regional Hospital","NETWORK",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":645,"enrollmentInfo":646,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":654,"leadSponsor":656,"locationsCount":45},"100562451","sequencing-in-inflammatory-bowel-diseases-ibd-therapy-the-latium-net-100562451","NCT06603337","Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: \"the Latium Net\".","Sequencing in Inflammatory Bowel Diseases (IBD) Therapy: \"the Latium Net\". A Key Multicenter Study","STRIKE","Inclusion Criteria:\n\n1. Age 18 to 70 years\n2. Patients with a previous diagnosis of CD or UC at least 3 months before baseline.\n3. Patients who have already failed at least one advanced (biological or small molecule) therapy for IBD and who have experienced failure to at least one mechanism of action (failure is defined as primary failure, secondary failure, or intolerance).\n4. Patients who have already started a new advanced therapy for IBD based on clinical practice indication (primary loss of response, secondary loss of response, intolerance to the previous drug) since at least 1 week and up to 8 weeks after starting it.\n5. Written informed consent certifying the willingness of the subject to participate to the study.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years.\n2. Patients with diagnosis of indeterminate colitis.\n3. Patients naive to advanced (biological or small molecule) therapy for IBD.\n4. Refusal to sign written informed consent certifying the willingness of the subject to participate to the study.","70 Years",{"count":647,"type":21},2700,"Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively:\n\n* Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included.\n* Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological\u002Fsmall molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, more than one molecule is allowed), and who belong to the Lazio Regional Health System.\n\nEligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months.\n\nPotential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.",[26],"2024-09-18",{"date":652,"type":37},"2024-09-19",{"date":650,"type":37},{"date":655,"type":21},"2028-10-01",{"name":657,"class":106},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]