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Colitis, Ulcerative clinical trials

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NCT ID: NCT05999708 Withdrawn - Colitis, Ulcerative Clinical Trials

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants

Start date: October 31, 2023
Phase: Phase 1
Study type: Interventional

This is a 3-part First Time in Human (FTIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of GSK4381406 following administration of single ascending doses (Part 1), repeat ascending doses (Part 2), and repeat doses with an indomethacin challenge (Part 3) in healthy adult participants. Part 1 consists of 4 planned cohorts with up to 2 treatment periods in each and is expected to have 6 doses (but can accommodate up to 7 doses). The impact of food on PK of GSK4381406 will also be assessed. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels. Part 3 will evaluate the impact of repeat doses of GSK4381406 versus placebo on indomethacin induced changes in small intestinal permeability in healthy participants.

NCT ID: NCT05652491 Withdrawn - Ulcerative Colitis Clinical Trials

The Role of Gut Microbiome in Predicting Comorbidities and Complications in Children With Inflammatory Bowel Disease

Start date: December 9, 2022
Phase:
Study type: Observational

Background: Bacteria and other microorganisms that live in the intestines (the gut microbiome) play an important role in a person s health. The gut microbiome helps to regulate the immune system and control inflammation. Imbalances in the gut microbiome have been linked to illnesses such as inflammatory bowel disease (IBD). People diagnosed with IBD can have serious health problems. Researchers want to know more about how the gut microbiome affects the development and progression of IBD in children. In this natural history study, they will compare the gut microbiomes of healthy children with those who have IBD. Objective: To collect stool and samples of intestine tissue from children with and without IBD undergoing colonoscopy. Eligibility: People under 21 years old who are having a colonoscopy at the Inova Health System or Pediatric Specialists of Virginia. Design: Participants will fill out a questionnaire. They will answer questions about their history. Topics may include how they were fed as infants; how they were born; and how often they took antibiotics. Stool and tissue samples from the intestines will be taken during the participants colonoscopy. They may also give samples of blood and urine. Participants may be asked to provide additional stool, blood, and urine samples. They may do this up to 3 times per year. These samples may be collected at the clinic; they may also be collected at home and mailed to the researchers. If they have more colonoscopies, participants may be asked for more tissue samples. Participants will be enrolled for up to 10 years. ...

NCT ID: NCT05578508 Withdrawn - Crohn's Disease Clinical Trials

Stem Cells for the Treatment of Pouchitis

Start date: April 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with medically refractory Pouchitis.

NCT ID: NCT05121402 Withdrawn - Ulcerative Colitis Clinical Trials

Safety and Efficacy Study of TLL018 in the Treatment of Ulcerative Colitis

Start date: December 30, 2022
Phase: Phase 2
Study type: Interventional

A study to investigate the safety and efficacy of TLL018 compared with placebo in subjects with moderate to severe ulcerative colitis.

NCT ID: NCT04898348 Withdrawn - Ulcerative Colitis Clinical Trials

A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis

Start date: January 14, 2022
Phase: Phase 2
Study type: Interventional

The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative colitis.

NCT ID: NCT04469062 Withdrawn - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

LUCENT-ACT
Start date: April 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT04348890 Withdrawn - Clinical trials for Pediatric Ulcerative Colitis

Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

Start date: September 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, multi-center, open-label proof-of-concept study of vamorolone. Twenty participants with a flare of mild or moderately active Ulcerative Colitis (defined as a Pediatric Ulcerative Colitis Activity Index [PUCAI] 10-60) will be enrolled and receive vamorolone 6 mg/kg/day orally once daily for 8 weeks.

NCT ID: NCT04259060 Withdrawn - Ulcerative Colitis Clinical Trials

Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission

HARBOUR
Start date: January 2024
Phase: Phase 2
Study type: Interventional

This is a 4-week pilot, multicenter, randomized, double-blinded placebo controlled trial of hydroxocobalamin and butyrate in ulcerative colitis (UC) that will occur in two phases. The main objectives of this study are to determine the capacity of hydroxocobalamin and butyrate to reduce calprotectin in those with inflammatory disease in UC to determine the safety and preferential dose of hydroxocobalamin with butyrate in UC.

NCT ID: NCT04209556 Withdrawn - Ulcerative Colitis Clinical Trials

A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis

NCT ID: NCT04202211 Withdrawn - Ulcerative Colitis Clinical Trials

FMT for Remission of Active Ulcerative Colitis in Adults

Start date: March 2022
Phase: Phase 2
Study type: Interventional

The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.