Ulcerative Colitis (Disorder)

10

Review clinical trials related to Ulcerative Colitis (Disorder). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA

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. IBD, 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. Participants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal/day) 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/BIVA, vitamin B12/D, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score). The 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.

Participants needed: 146
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Lionhealth Srl Società BenefitUpdated: Jun 25, 2026Locations: 4
Eligibility criteria

Age 18-65 years [+4]

Following an exclusion diet (CDED) [+3]

Status: Recruiting

A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult

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.

Participants needed: 68
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: Benethera (Shaoxing) Biotechnology Co., Ltd.Updated: Jun 8, 2026Locations: 1
Eligibility criteria

WOCBP is defined as any female who has experienced menarche and has not undergon... [+1]

1. As determined by the investigator, known or persistent psychiatric disorders...

Status: Recruiting

Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease

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. ButyMixx contains: * Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation. * A "beneficial" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota. It will also learn about the safety of dietary supplement. The main questions it aims to answer are: * Does ButyMixx after 2 months of supplementation * Symptoms improve, * Quality of life improves, * Intestinal inflammation decreases , * The gut microbiota becomes more "balanced" * What medical problems do participants have when taking ButyMixx ? Participants will: * Take 2 sachets of ButyMixx per day for 8 weeks * Before starting and at the end of the 8 weeks: * Provide a stool sample * Complete a quality-of-life questionnaire * Be assessed by a doctor using a symptom score

Participants needed: 40
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: University of PadovaUpdated: May 15, 2026Locations: 1
Eligibility criteria

Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence... [+2]

Patients that have active UC, determined by clinical, endoscopic and histopathol... [+4]

Status: Not yet recruiting

Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy

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. The 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. Adults 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. This 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.

Participants needed: 480
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Region StockholmUpdated: Mar 20, 2026Locations: 1
Eligibility criteria

Extensive ulcerative colitis or indeterminate colitis (IBD-U), or Crohn's coliti... [+2]

History of colorectal cancer or prior colectomy [+4]

Status: Recruiting

Efficacy and Safety of Etrasimod in Elderly Patients With Ulcerative Colitis

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.

Participants needed: 30
Trial details
Biological sex: AllType: InterventionalSponsor: Showa Inan General HospitalUpdated: Dec 11, 2025Locations: 1
Eligibility criteria

Patients with active ulcerative colitis

the presence of acute or chronic renal failure, chronic heart disease, pulmonary...

Status: Recruiting

Effects of Pomegranate Juice on Ulcerative Colitis

The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will: 1. lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life 2. affect the microbes living in the gut (gut microbiota)

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of California, Los AngelesUpdated: Dec 9, 2025Locations: 2
Eligibility criteria

• Adults ≥ 18 yo [+7]

• Non-English speaker [+19]

Status: Not yet recruiting

Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion

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. The 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/or surgeons. The 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. However, 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. To 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. The 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: * unexposed group: no preoperative stoma identification and education * exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery. Total 100 patients : * In scheduled surgery: 30 exposed and 30 unexposed patients * In emergency surgery: 10 exposed and 30 unexposed patients Timeline: Inclusion period: 12 months Follow-up period: 12 months Total duration: 24 months

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique Hopitaux De MarseilleUpdated: Nov 18, 2025Locations: 1
Eligibility criteria

Men or women aged 18 and over [+2]

Patient in a period of exclusion from another research protocol at the time of s... [+3]

Status: Not yet recruiting

Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)

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. Recently, 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. The goal of this study is to assess the benefits of a multimodal day hospital on the management and skills of patients with IBD.

Participants needed: 240
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Sep 11, 2025Locations: 1
Eligibility criteria

Patient diagnosed with ulcerative colitis and Crohn's disease for more than 3 mo... [+3]

Protective measure in place. [+2]

Status: Recruiting

Study of Tissue Repair in Inflammatory Bowel Disease Exploiting Organoid Technology

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. To 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. Given these premises, the investigators propose the following objectives: Primary objective: The 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. The 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. Secondary objective The secondary goals of this study are: \- 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. Namely the investigators will evaluate the following parameters: * Their capacity to proliferate. * Their ability to survive treatment with pro-inflammatory cytokines * The activation of intracellular pathways associated with cell death. * Their overall metabolic activity. * The balance between stem and differentiated epithelial cell types. * The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival. * 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: * The abundance of proliferating cells. * The activation of intracellular pathways associated with cell death and survival. * Their overall metabolic activity. * The balance between stem and differentiated epithelial cell types. * The transcriptional activation of protective pathways such as those associated with proliferation, migration, differentiation and cell survival.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique Hopitaux De MarseilleUpdated: Aug 22, 2025Locations: 1
Eligibility criteria

Patients of either sex aged 18 years or older [+26]

Status: Recruiting

The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis

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.

Participants needed: 450
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Humanitas Clinical and Research CenterUpdated: Nov 15, 2024Locations: 1
Eligibility criteria

Established diagnosis of UC according to the current European Crohn's and Coliti... [+7]

Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory condi... [+6]