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Colitis clinical trials

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NCT ID: NCT04897282 Recruiting - Ulcerative Colitis Clinical Trials

Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI Biomarker Panel and Algorithm to Detect Mucosal Healing in Moderate to Severe Ulcerative Colitis Patients.

Start date: August 24, 2021
Phase:
Study type: Observational

The purpose of this research study is to determine the efficacy and outcome of the UCRI (an in-vitro diagnostics device in the form of a blood test and an algorithm) as a tool to detect mucosal healing (level of inflammation in the colon) in people with moderate-to-severe ulcerative colitis treated with anti-TNFα. Another reason is to explore additional biomarkers in blood, stool or voice to detect disease activity and/or mucosal healing. A tool to detect the level of inflammation in the colon based on blood, stool or voice biomarkers may reduce the need or the number of invasive endoscopic procedures. This is an observational study and no treatment decision nor clinical intervention will be done based on results during this study and all collected data will be used only for the goal of the study and for obtaining FDA IDE for a follow-up study.

NCT ID: NCT04883840 Recruiting - Ulcerative Colitis Clinical Trials

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

ReMiDy
Start date: October 22, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

- Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) - Evaluation of the microbiota modulation potential of statins in Bact2- enterotyped, healthy volunteers and ulcerative colitis patients. - Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients. - Evaluation of reduced inflammatory parameters of participants involved in trial

NCT ID: NCT04882683 Recruiting - Ulcerative Colitis Clinical Trials

Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.

NCT ID: NCT04882007 Recruiting - Ulcerative Colitis Clinical Trials

Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

CoTikiS
Start date: October 2, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

NCT ID: NCT04879966 Recruiting - Clinical trials for Moderate to Severe Ulcerative Colitis

A Cohort Study Comparing IFX to CS for Moderate to Severe UC

INSURE
Start date: May 17, 2021
Phase:
Study type: Observational

The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.

NCT ID: NCT04844606 Recruiting - Ulcerative Colitis Clinical Trials

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

SHINE-ON
Start date: May 26, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.

NCT ID: NCT04799496 Recruiting - Crohn Disease Clinical Trials

A Study of Kynteles Injection (Vedolizumab) in Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease or Chronic Pouchitis

Start date: June 10, 2020
Phase:
Study type: Observational

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice. The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

NCT ID: NCT04797325 Recruiting - Clinical trials for Immune-Mediated Colitis

Vedolizumab for Immune Mediated Colitis

Start date: August 30, 2021
Phase: Phase 2
Study type: Interventional

This is an open label randomized trial to evaluate the efficacy and treatment duration with vedolizumab to patients with immune mediated colitis. The trial will include 82 patients randomized into two arms, either standard treatment with prednisolone (plus infliximab in severe cases) or vedolizumab treatment up front.

NCT ID: NCT04779307 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Start date: April 18, 2022
Phase: Phase 3
Study type: Interventional

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

NCT ID: NCT04768504 Recruiting - Clinical trials for Immune-Mediated Colitis

Tofacitinib for the Treatment of Refractory Immune-related Colitis From Checkpoint Inhibitor Therapy- TRICK Study

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

This is a single-arm pilot study evaluating the efficacy and safety of tofacitinib in cancer patients with immune-related colitis from immune checkpoint inhibitor (ICI) therapy.