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Colitis, Ulcerative clinical trials

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NCT ID: NCT06029972 Recruiting - Ulcerative Colitis Clinical Trials

Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis

PALEKONA
Start date: December 5, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

NCT ID: NCT06026449 Recruiting - Ulcerative Colitis Clinical Trials

Gluten-free Diet in PSC and IBD

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study. Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.

NCT ID: NCT06025227 Available - Colitis, Ulcerative Clinical Trials

Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.

Start date: n/a
Phase:
Study type: Expanded Access

Provide pre-approval single patient Expanded Access (Compassionate Use) of Etrasimod for patients.

NCT ID: NCT06013696 Active, not recruiting - Ulcerative Colitis Clinical Trials

Bleach and Urine Color in UC Patients Using 5ASA

Asableach
Start date: July 16, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA

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: NCT05998213 Recruiting - Ulcerative Colitis Clinical Trials

Transfer of Feces in Ulcerative Colitis 2

TURN2
Start date: December 5, 2018
Phase: Phase 2
Study type: Interventional

The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis. Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas). Donors are selected based on microbiota profile.

NCT ID: NCT05992142 Completed - Ulcerative Colitis Clinical Trials

ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

CARUC-ASA
Start date: January 17, 2023
Phase: Phase 4
Study type: Interventional

For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.

NCT ID: NCT05988528 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

Start date: August 20, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life. Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development

NCT ID: NCT05987852 Recruiting - Ulcerative Colitis Clinical Trials

Hyperbaric Oxygen Therapy for Ulcerative Colitis

HBOT-UC
Start date: January 9, 2024
Phase: N/A
Study type: Interventional

Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.

NCT ID: NCT05976802 Not yet recruiting - Ulcerative Colitis Clinical Trials

Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Start date: June 2024
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).