[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,52,87,116,145,166,186,213,237,258],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100626308","partial-enteral-nutrition-to-prevent-weight-loss-and-sarcopenia-in-ibd-patients-at-nutritional-risk---simba-100626308",false,"NCT07433946","Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA","Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA","SIMBA","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Crohn's Disease or Ulcerative Colitis\n* At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)\n* Ability to provide informed consent\n* Women of childbearing potential must use effective contraception\n\nExclusion Criteria:\n\n* Following an exclusion diet (CDED)\n* Current hospitalization\n* Pregnancy\n* Requirement for a low-protein diet","ALL","18 Years","65 Years",{"count":21,"type":22},146,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers.\n\nIBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk.\n\nParticipants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal\u002Fday) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA\u002FBIVA, vitamin B12\u002FD, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score).\n\nThe study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.",[28,29,30,31],"Ulcerative Colitis (Disorder)","Crohn Disease","Malnutrition or Risk of Malnutrition","IBD",[31,33,34,35,36,37,38],"Malnutrition","Sarcopenia","ONS","enteral nutrition","weight loss","clinical nutrition","RECRUITING","2026-06-22",{"date":42,"type":43},"2026-06-25","ACTUAL",{"date":45,"type":43},"2026-03-09",{"date":47,"type":22},"2027-01-31",{"name":49,"class":50},"Lionhealth Srl Società Benefit","INDUSTRY",4,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"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":62,"type":22},68,[64],"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.",[67,28,68,69,70],"Ulcerative Colitis (UC)","Ulcerative Colitis Acute","IBD (Inflammatory Bowel Disease)","CD - Crohn's Disease",[72,73,74,31,75,76],"Crohn's disease","Ulcerative Colitis","Inflammatory Bowel Disease","CD","UC","2026-06-02",{"date":79,"type":43},"2026-06-08",{"date":81,"type":43},"2026-05-18",{"date":83,"type":22},"2027-02-28",{"name":85,"class":50},"Benethera (Shaoxing) Biotechnology Co., Ltd.",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":86},"100637527","sodium-butyrate-and-kluyveromyces-marxianus-supplementation-in-inflammatory-bowel-disease-100637527","NCT07591012","Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease","Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment","Butymixx","Inclusion Criteria:\n\n* Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.\n* Age between 18 and 75 years old\n* Ability of subject to participate fully in all aspects of this clinical trial.\n\nExclusion Criteria:\n\n* Patients that have active UC, determined by clinical, endoscopic and histopathological evidence\n* Known diagnosis of CD( Crohn disease), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis\n* Positive stool culture for active C. difficile\n* Pregnant women\n* Patients under antibiotic and\u002For probiotic treatment within 10 days prior to Visit 1.","75 Years",{"count":97,"type":22},40,[25],"The goal of this clinical trial is to learn if a dietary supplement called ButyMixx can help people with ulcerative colitis in remission feel better and keep their intestines less inflamed.\n\nButyMixx contains:\n\n* Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation.\n* A \"beneficial\" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota.\n\nIt will also learn about the safety of dietary supplement. The main questions it aims to answer are:\n\n* Does ButyMixx after 2 months of supplementation\n\n  * Symptoms improve,\n  * Quality of life improves,\n  * Intestinal inflammation decreases ,\n  * The gut microbiota becomes more \"balanced\"\n* What medical problems do participants have when taking ButyMixx ?\n\nParticipants will:\n\n* Take 2 sachets of ButyMixx per day for 8 weeks\n* Before starting and at the end of the 8 weeks:\n\n  * Provide a stool sample\n  * Complete a quality-of-life questionnaire\n  * Be assessed by a doctor using a symptom score",[28],[102,103,104,105],"Ulcerative colitis","Butyrate","Kluyveromyces marxianus","Yearst","2026-05-12",{"date":108,"type":43},"2026-05-15",{"date":110,"type":22},"2026-05-01",{"date":112,"type":22},"2027-03-30",{"name":114,"class":115},"University of Padova","OTHER",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":140,"leadSponsor":142,"locationsCount":86},"100599844","virtual-versus-dye-based-chromoendoscopy-in-inflammatory-bowel-disease-surveillance-colonoscopy-100599844","NCT07089771","Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy","Inclusion Criteria:\n\n* Age ≥ 18 years and one of the criteria beneath:\n* Extensive ulcerative colitis or indeterminate colitis (IBD-U), or Crohn's colitis involving at least one-third of the colon, with a disease history of at least 8 years\n* IBD or IBD-U with primary sclerosing cholangitis (PSC)\n* IBD or IBD-U with a family history of colorectal cancer in a first-degree relative\n\nExclusion Criteria:\n\n* History of colorectal cancer or prior colectomy\n* Contraindications to dye use\n* Colonoscopies for therapeutic purposes\n* Pregnancy\n* Inability to consent",{"count":123,"type":22},480,[25],"People with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease affecting the colon, have a higher risk of developing colon cancer over time. To catch early signs of cancer, regular colonoscopies are recommended. In this study, the investigators are comparing two advanced methods of examining the colon during these surveillance colonoscopies. One method uses a special dye sprayed inside the colon to highlight abnormal areas (called dye-based chromoendoscopy). The other method uses new technology built into the camera to enhance the view without needing any dye (called virtual chromoendoscopy). Both methods use modern, high-definition equipment.\n\nThe purpose of this study is to find out if the newer, dye-free method is as good as the traditional dye method at detecting pre-cancerous changes (called dysplasia) in people with IBD.\n\nAdults with IBD who are due for a routine surveillance colonoscopy may be invited to take part. Participants will be randomly assigned to one of the two methods. No additional procedures are involved, and only the way the colon is viewed differs. The investigators will also look at how long the procedures take, how many biopsies are needed, any complications, and how patients experience the exam. Participants will be followed over time using national health records to check for long-term outcomes.\n\nThis research will help doctors better understand which method is most effective and comfortable for patients, and may guide future recommendations for cancer screening in people with IBD.",[127,28,128,129],"Inflammatory Bowel Disease (IBD)","Crohns Disease","Colorectal Neoplasms",[131,132,133,134],"virtual chromoendoscopy","dye-based chromoendoscopy","dysplasia detection","IBD surveillance colonoscopy","NOT_YET_RECRUITING","2026-03-18",{"date":138,"type":43},"2026-03-20",{"date":110,"type":22},{"date":141,"type":22},"2032-12-31",{"name":143,"class":144},"Region Stockholm","OTHER_GOV",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":86},"100611673","efficacy-and-safety-of-etrasimod-in-elderly-patients-with-ulcerative-colitis-100611673","NCT07243639","Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis","A Prospective Study on the Efficacy and Safety of a Novel Oral Drug, Etrasimod, in Elderly Patients With Ulcerative Colitis","Inclusion Criteria:\n\n* Patients with active ulcerative colitis\n\nExclusion Criteria:\n\n* the presence of acute or chronic renal failure, chronic heart disease, pulmonary infection, liver cirrhosis, colorectal cancer, autoimmune disease, and infectious disease",{"count":153,"type":22},30,[25],"Eligible patients will be identified in regular clinical practice. After providing thorough explanation and obtaining voluntary written informed consent, the clinical course, adverse events, endoscopic findings, and histopathological changes in biopsy specimens after Etrasimod administration will be prospectively collected and analyzed.",[28],"2025-12-09",{"date":159,"type":43},"2025-12-11",{"date":161,"type":43},"2025-10-01",{"date":163,"type":22},"2026-09-30",{"name":165,"class":115},"Showa Inan General Hospital",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100601850","effects-of-pomegranate-juice-on-ulcerative-colitis-100601850","NCT07115862","Effects of Pomegranate Juice on Ulcerative Colitis","Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study","Inclusion Criteria:\n\n* • Adults ≥ 18 yo\n\n  * Following a low-polyphenol and fiber diet (\\\u003C 3 servings of fruits\u002Fvegetables per day)\n  * Mild-to-moderate UC at the time of screening (2 ≤ partial Mayo scores ≤ 5)\n  * Supportive evidence of active inflammation (hsCRP \\>1 mg\u002FL, fecal calprotectin \\>50 µg\u002Fg stool, or abnormal lower endoscopy) in individuals with biopsy-proven UC\n  * Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior to screening\n  * Patients on treatment with immunosuppressive therapy (e.g., azathioprine\u002F6-mercaptopurine, methotrexate) must be on stable dose for 8 weeks prior to baseline visit\n  * At the time of baseline visit, patients may be on no more than 20 mg\u002Fday of prednisone and 9 mg\u002Fday of budesonide MMX\n  * Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.\n\nExclusion Criteria:\n\n* • Non-English speaker\n\n  * Vegetarian\u002Fvegan\n  * Known pomegranate allergy\n  * Documented chronic disease besides UC, including diabetes, renal or liver diseases, metabolic syndrome, active cancer, MI or stroke, history of gastric bypass\n  * Patients with CD, indeterminate\u002Fsevere to fulminant colitis\n  * History of colectomy or colonic dysplasia\n  * Presence of ileal pouch or ostomy\n  * Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova \\& parasites, Clostridium difficile, and stool culture\n  * Recent hospitalizations (within 2 weeks of screening) for UC requiring IV steroids\n  * Presence of the following labs indicative of severe colitis: a. Hemoglobin \\\u003C 8.0 g\u002Fdl b. Albumin \\\u003C 3.0 g\u002Fdl\n  * Recent systemic antibiotics use (within 3 months of screening) or active use of anti-diarrheal medications\n  * Taking supplements known to affect metabolism or gut microbiota composition (probiotics, fiber, etc.), unless willing to stop for the study duration\n  * Use of Total Parenteral Nutrition (TPN)\n  * Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening\n  * Taking exogenous hormones (e.g., hormone replacement therapy)\n  * Recent weight fluctuations (\\>10% in the last 6 months)\n  * Smoker or living with a smoker\n  * Use of \\>20 g of alcohol per day\n  * Unable or unwilling to comply with the study protocol (including unwillingness to avoid watermelon and other lycopene-rich foods for the whole duration of the study)\n  * Unable to provide consent",{"count":153,"type":22},[25],"The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will:\n\n1. lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life\n2. affect the microbes living in the gut (gut microbiota)",[28],"2025-12-08",{"date":157,"type":43},{"date":180,"type":43},"2025-10-15",{"date":182,"type":22},"2027-10-15",{"name":184,"class":115},"University of California, Los Angeles",2,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":86},"100583820","impact-of-prior-identification-and-education-of-patients-requiring-a-digestive-stoma-for-fecal-diversion-100583820","NCT06881303","Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion","RESTODIG","Inclusion Criteria:\n\n* Men or women aged 18 and over\n* for whom a fecal diversion stoma is planned on a scheduled or emergency basis\n* affiliated with the French social security system\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),\n* No digestive stoma or fecal diversion planned\n* Person who does not understand French",{"count":194,"type":22},100,[25],"There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.\n\nThe positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and\u002For surgeons.\n\nThe impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.\n\nHowever, despite this \"Evidence Based Medicine\", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.\n\nTo this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.\n\nThe main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:\n\n* unexposed group: no preoperative stoma identification and education\n* exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.\n\nTotal 100 patients :\n\n* In scheduled surgery: 30 exposed and 30 unexposed patients\n* In emergency surgery: 10 exposed and 30 unexposed patients\n\nTimeline:\n\nInclusion period: 12 months Follow-up period: 12 months Total duration: 24 months",[198,199,200,28,201,29,202,203],"Colorectal Anastomosis","Endometrial","Anastomotic Leak Rectum","Adenomatous Polyposis Coli, Familial","Digestive Cancers","Protectomy","2025-11-17",{"date":206,"type":43},"2025-11-18",{"date":208,"type":22},"2026-03-01",{"date":210,"type":22},"2028-03-01",{"name":212,"class":115},"Assistance Publique Hopitaux De Marseille",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":86},"100605797","evaluation-of-a-multimodal-day-hospital-for-the-overall-management-of-patients-with-chronic-inflammatory-bowel-diseases-ibd-100605797","NCT07167186","Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)","AMBUMIC","Inclusion Criteria:\n\n* Patient diagnosed with ulcerative colitis and Crohn's disease for more than 3 months, with a confirmed diagnosis according to European guidelines, being followed in the gastroenterology department at Saint Antoine Hospital.\n* Aged over 18 years.\n* Undergoing a multimodal day hospital visit, regardless of the scheduled intervention in the gastroenterology department at Saint Antoine Hospital.\n* Not opposed to participating in the research.\n\nExclusion Criteria:\n\n* Protective measure in place.\n* Patient who has previously participated in an equivalent day hospital program.\n* Pregnant woman.",{"count":221,"type":22},240,"OBSERVATIONAL","Inflammatory bowel diseases (IBD) are long-term conditions affecting more than 250,000 people in France. They typically begin in young adults and are characterized by flare-ups interspersed with periods of remission. The impact of these diseases goes beyond digestive symptoms, with fatigue present in 50 to 80% of cases. The overall effect on health leads to a decline in quality of life and work productivity. Therapeutic management relies on long-term immunosuppressive treatments aimed at inducing prolonged remission. While therapeutic management has become more complex with an increasing number of available treatments, evaluating the effectiveness and tolerance of these treatments requires a multimodal approach, including therapeutic education and specific follow-up based on the patient's profile and treatment, with the goal of comprehensive care and precision medicine.\n\nRecently, multimodal day hospitalizations have been developed, particularly in response to the recent evolution of treatment administration routes toward subcutaneous or oral forms. In 2022, the gastroenterology and nutrition department of Saint Antoine Hospital, which follows 3,500 patients with CIBD, created a multimodal day hospital (DH) (four interventions) dedicated to patients treated with biologics and Janus kinase inhibitors. In a single session, this approach systematically combines (1) specific biological tests, especially pharmacokinetics, (2) a consultation with a gastroenterologist, (3) a consultation with a therapeutic education nurse, (4) and, depending on the identified needs of the patients, a dietary workshop or fatigue management session; a specialized dermatology or rheumatology consultation; and an ultrasound of the intestinal wall.\n\nThe goal of this study is to assess the benefits of a multimodal day hospital on the management and skills of patients with IBD.",[127,29,28],[226,227,72,102],"Therapeutic education","Inflammatory bowel disease","2025-09-03",{"date":230,"type":43},"2025-09-11",{"date":232,"type":22},"2025-09",{"date":234,"type":22},"2026-07",{"name":236,"class":115},"Assistance Publique - Hôpitaux de Paris",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":86},"100578022","study-of-tissue-repair-in-inflammatory-bowel-disease-exploiting-organoid-technology-100578022","NCT06805890","Study of Tissue Repair in Inflammatory Bowel Disease Exploiting Organoid Technology","ORGANOIDS","For IBD group the inclusion criteria will be:\n\n* Patients of either sex aged 18 years or older\n* Patient that have read the information form and signed consent\n* Patient covered with health insurance\n* Patients with Crohn's Disease or ulcerative colitis in accordance with accepted clinical, endoscopic, histological and\u002For radiologic criteria, regardless of the level, severity of the disease or duration of disease progression.\n* Patients with colonic involvement of Crohn's disease or ulcerative colitis\n* Patients undergoing a screening colonoscopy in the context of IBD disease follow-up OR undergoing intestinal resection for IBD disease aggravation\n\nFor control group the inclusion criteria will be:\n\n* Patients of either sex aged 18 years or older\n* Patient that have read the information form and signed consent\n* Patient covered with health insurance\n* Patients undergoing a screening colonoscopy in the context of a family history of colonic neoplasia, follow-up of colonic polyps or functional intestinal disorders OR undergoing intestinal resection for intestinal neoplasia, occlusive syndrome or colostomy\n\nThe non-inclusion criteria for IBD group will be:\n\n* Contraindication to the anaesthetic or colonoscopy procedure\n* Patients without colonic involvement of Crohn's disease or ulcerative colitis\n* Patients of Adults without legal capacity\n* Patients in Health and Social Establishments\n* Persons in emergency situations\n* Persons deprived of their liberty\n* Non-affiliated to a social security scheme\n* Absence or refusal of the informed consent\n\nThe non-inclusion criteria for control group will be:\n\n* IBD disease revealed during colonoscopy or gastrointestinal resection\n* Patient suffering from Immune-Mediated Inflammatory Diseases (IMIDs)\n* Contraindication to the anaesthetic or colonoscopy procedure\n* Patients of Adults without legal capacity\n* Patients in Health and Social Establishments\n* Persons in emergency situations\n* Persons deprived of their liberty\n* Non-affiliated to a social security scheme\n* Absence or refusal of the informed consent",{"count":245,"type":22},60,[25],"Inflammatory Bowel Diseases (IBD) are chronic inflammations of the gastrointestinal tract. Regardless of the etiology, a common trait of IBD pathogenesis is the inflammatory damage inflicted on the intestinal mucosa and the loss of intestinal epithelial barrier integrity. Therefore, understanding the mechanisms that govern IEC's capacity to maintain barrier function and to orchestrate mucosal healing is considered a major goal in translational research. The investigators are interested in understanding how the inflammatory environment present in the intestinal mucosa, of IBD patients influences epithelial cells capacity to govern repair. The complexities of the cytokine and metabolic milieu present in IBD patients render the study of the contribution of each cytokine, metabolite, and intracellular pathway extremely complicated. Therefore, most of the processes that govern tissue regeneration are studied with the use of mouse models that recapitulate one or multiple features of IBD and allow for genetical modifications of the gene and pathway of interest. While mouse models are uniquely suited to study the complex crosstalk between the immune system, the microbiota, and the intestinal epithelia, they introduce the important problem of species-specific differences, which can hamper the translational value of mouse studies.\n\nTo overcome these shortcomings, the investigators propose to explore the influence of cytokines and metabolites in digestive organoids derived from patients and controls. Importantly, it was demonstrated that gene expression and innate immune responses are altered in primary organoids derived from patients with IBD, including altered ability to proliferate, respond to cytokines, metabolic capacity, and efficiently form organoids suggesting that major differences between patient's and control's epithelial cell biology can be faithfully replicated in this system.\n\nGiven these premises, the investigators propose the following objectives:\n\nPrimary objective:\n\nThe main objective of this study is to establish that patient's epithelial cells from inflamed mucosae have decreased ability to repair the intestinal mucosa, as compared to epithelial cells from non-inflamed regions in the same patient, or to control subject with no inflammatory digestive diseases.\n\nThe investigators will explore this question both deriving organoids from clinical samples and exposing them to pro inflammatory cytokines and metabolites in vitro, as well as by analyzing repair responses from the aforementioned clinical samples ex vivo.\n\nSecondary objective\n\nThe secondary goals of this study are:\n\n\\- To compare organoids derived from: epithelia in inflamed mucosa of IBD patients, epithelia in non-inflamed mucosa of IBD patients, and epithelia from the mucosa of non-IBD controls in their capacity to mount a repair response in response to inflammatory cytokines or luminal metabolites.\n\nNamely the investigators will evaluate the following parameters:\n\n* Their capacity to proliferate.\n* Their ability to survive treatment with pro-inflammatory cytokines\n* The activation of intracellular pathways associated with cell death.\n* Their overall metabolic activity.\n* The balance between stem and differentiated epithelial cell types.\n* The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival.\n* To evaluate hallmarks of tissue repair in biopsies derived from epithelia in inflamed mucosa of IBD patients, epithelia in non-inflamed mucosa of IBD patients, and epithelia from the mucosa of non-IBD controls, and to correlate them to the levels of inflammatory cytokines, luminal metabolites and overall disease severity. Namely the investigators will evaluate the following parameters:\n* The abundance of proliferating cells.\n* The activation of intracellular pathways associated with cell death and survival.\n* Their overall metabolic activity.\n* The balance between stem and differentiated epithelial cell types.\n* The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival.",[29,249,28],"Inflammatory Bowel Diseases (IBD)","2025-08-21",{"date":252,"type":43},"2025-08-22",{"date":254,"type":43},"2025-07-24",{"date":256,"type":22},"2027-03-24",{"name":212,"class":115},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":222,"phases":4,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":86},"100569193","the-podium-study---a-three-arm-comparison-of-target-therapies-after-anti-tnf-in-ulcerative-colitis-100569193","NCT06691061","The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis","Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance","Inclusion Criteria:\n\n* Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;\n* Age ≥ 18 years-old;\n* Capability of expressing informed consent;\n* Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;\n* Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;\n* Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and\u002For golimumab);\n* No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;\n* At least 1 follow-up visit after baseline\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;\n* Age \\\u003C 18 years-old;\n* Incapability of expressing informed consent;\n* Acute severe UC requiring hospitalization at baseline;\n* No previous exposure to anti-TNFα therapies;\n* Previous treatment with target therapies other than anti-TNF-α for UC before baseline;\n* Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.",{"count":266,"type":22},450,"The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.",[28],"2024-11-14",{"date":271,"type":43},"2024-11-15",{"date":273,"type":43},"2023-08-01",{"date":275,"type":22},"2024-12-31",{"name":277,"class":115},"Humanitas Clinical and Research Center"]