TrialPath
Ulcerative colitis

Ulcerative colitis clinical trials — recruiting now

There are 20+ ulcerative colitis studies currently recruiting participants across the US. Every eligibility criterion translated into plain English.

Nicotinamide Riboside in Ulcerative Colitis

NCT05561738 · Ulcerative Colitis
Recruiting

This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).

PhaseNA
TypeInterventional
Age18 Years
WherePittsburgh, Pennsylvania, United States
SponsorUniversity of Pittsburgh
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Treatment of UC With Novel Therapeutics

Recruiting

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study.

PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereChestnut Hill, Massachusetts, United States
SponsorBrigham and Women's Hospital
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Piloting an Insomnia Treatment in Patients With Ulcerative Colitis

NCT07428629 · Insomnia, Ulcerative Colitis
Recruiting

The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are: * Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants? * Does CBT-I for UC impact insomnia severity and sleep continuity? Participants will: * Answer questionnaires online before and after treatment * Complete an online daily sleep diary before, during, and after treatment * Participate in 5 telehealth treatment visits over 7-8 weeks * Participate in 5-10-minute phone calls between treatment visits

PhaseNA
TypeInterventional
Age18 Years
WhereLebanon, New Hampshire, United States
SponsorDartmouth-Hitchcock Medical Center
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A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Recruiting

The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

PhasePhase 3
TypeInterventional
Age2 Years
WhereMobile, Alabama, United States + 97 more
SponsorTakeda
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A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants

NCT06627556 · Ulcerative Colitis
Recruiting

The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.

PhasePhase 1
TypeInterventional
Age18 Years – 55 Years
WhereMelbourne, Victoria, Australia
SponsorJiangsu Carephar Pharmaceutical Co., Ltd.
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A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea

Recruiting

The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.

Phase
TypeObservational
Age18 Years
WhereGoyang-si, Gyeonggi-do, South Korea
SponsorTakeda
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Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.

NCT05895981 · Ulcerative Colitis
Recruiting

Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents. The aim of this exploratory Clinical Trial is to evaluate the safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis.

PhaseNA
TypeInterventional
Age18 Years
WhereXi'an, Shaanxi, China
SponsorXijing Hospital
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Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis

Recruiting

Brief summary The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).

PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 75 Years
WhereScottsdale, Arizona, United States + 65 more
SponsorXencor, Inc.
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Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

NCT04535882 · LRG Levels
Recruiting

We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

Phase
TypeObservational
AgeAny
WhereKomagane, Nagano, Japan
SponsorShowa Inan General Hospital
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Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Recruiting

The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.

PhasePhase 2
TypeInterventional
Age18 Years
WhereHouston, Texas, United States
SponsorThe University of Texas Health Science Center, Houston
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A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Recruiting

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereChandler, Arizona, United States + 206 more
SponsorEli Lilly and Company
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Safety and Efficacy of Fecal Microbiota Transplantation

NCT04014413 · Crohn Disease, Ulcerative Colitis, Celiac Disease
Recruiting

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.

PhaseNA
TypeInterventional
AgeAny
WhereHong Kong, Shatin, Hong Kong
SponsorChinese University of Hong Kong
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Digestive Biobank for Exploring Microbiota-host Interactions

Recruiting

Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.

Phase
TypeObservational
Age18 Years
WhereParis, France
SponsorAssistance Publique - Hôpitaux de Paris
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Argentine Registry of Crohn's Disease and Ulcerative Colitis

NCT07155148 · Epidemiology, Inflammatory Bowel Disease (IBD), Therapy
Recruiting

RADECCU is a strictly observational IBD registry in Argentina. The registry is open to all practicing gastroenterologist in the country grouped within the Argentinean Crohn's and Ulcerative Colitis Group (GADECCU). The registry will include outcomes of routine clinical practice of patients with IBD including the pediatric and adult population.

Phase
TypeObservational
AgeAny
WhereCórdoba, Córdoba Province, Argentina
SponsorGrupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa
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TIDHI Mental Health in IBD Patients Study

Recruiting

The purpose of this study is to test the impact of Healing Circuits™; a structured mental health support model on IBD patients. The eligible study participants will be randomly divided into two groups: 1. the group receiving structured mental health support with a social worker and 2. the group receiving structured mental health support via a self-directed online curriculum. Both groups will be receiving the same type of therapy, Healing Circuits™, but the group receiving the therapy via the online self-directed curriculum will be receiving the therapy mostly by web-based video instruction. The two groups will be evaluated over a period of 12 months.

PhaseNA
TypeInterventional
Age18 Years – 75 Years
WhereNorth York, Ontario, Canada
SponsorTIDHI Innovation Inc.
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Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Recruiting

The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab in patients with inflammatory bowel disease (IBD) that were previously treated with an optimized dose of intravenous infliximab. The main question it aims to answer is: \- Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab in patients who received an optimized intravenous dosing schedule? Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical practice in the monitoring for clinical and biological remission. The participants that are willing to switch to subcutaneous infliximab will be compared to a group of participants not willing to switch. These participants will continue to be treated with their optimized intravenous dose of infliximab.

PhasePhase 4
TypeInterventional
Age18 Years
WhereGhent, Oost-Vlaanderen, Belgium + 14 more
SponsorBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
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Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study.

NCT06862843 · Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), Ulcerative Colitis (UC)
Recruiting

The proposed study is part of a PNRR 2022 project (call "Non-Communicable Chronic Diseases (NCDs) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation of an observational clinical study named TRANSMIC, approved by the pediatric ethics committee of the Tuscany region. TRANSMIC was an integral part of a European research project within the joint programming initiative (JPI), under the HDHL-INTIMIC theme: "A Healthy Diet for a Healthy Life," aimed at understanding the cause-effect relationships between diet, gut microbiome, and human health. Understanding the role of diet in inflammatory bowel diseases (IBD) and exploring its role in autoimmune inflammatory conditions with joint manifestations, such as JIA, provides additional insights into the development, progression, and management of these conditions, opening new horizons for the use of dietary treatments in preventing these inflammatory conditions.

Phase
TypeObservational
AgeAny
WhereFlorence, Italy, Italy + 3 more
SponsorMeyer Children's Hospital IRCCS
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A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis

NCT06865417 · Ulcerative Colitis
Recruiting

The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years. Approximately 80 subjects from 8 to \<18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \<12 years of age, will be enrolled in this study. During the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food). Subjects who do not achieve mMCS remission and/or MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study. Subjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.

PhasePhase 3
TypeInterventional
Age8 Years – 18 Years
WhereBrussels, Brussels Capital, Belgium + 46 more
SponsorAlfasigma S.p.A.
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STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission

Recruiting

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

PhaseNA
TypeInterventional
Age18 Years – 75 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
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A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

NCT06073873 · Ulcerative Colitis
Recruiting

The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.

Phase
TypeObservational
Age19 Years
WhereSeoul, South Korea
SponsorBristol-Myers Squibb
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