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Colitis clinical trials

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NCT ID: NCT05430412 Recruiting - Ulcerative Colitis Clinical Trials

CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis

Start date: January 11, 2022
Phase: N/A
Study type: Interventional

The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical response to IFX will be evaluated through the PUCAI score. The response will be considered clinically significant if PUCAI points continue maintained below 30 during the study period. The IFX response will also be determined by IFX serum levels. A therapeutic IFX level, i.e. for achieving an adequate clinical response, is established above 6 μg/mL. Finally, the necessity, or not, of a steroid treatment during the study period will also be indicative of successful efficacy with GMA.

NCT ID: NCT05428345 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea

Start date: September 25, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05404074 Recruiting - Ulcerative Colitis Clinical Trials

Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis

Start date: November 22, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the PK, safety and tolerability of cobitolimod ememas (500mg/50mL) given to participants with active left-sided UC.

NCT ID: NCT05382715 Recruiting - Colitis, Ulcerative Clinical Trials

A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis

COLIBRI
Start date: May 30, 2022
Phase:
Study type: Observational

The purpose of this study is to monitor the use, effectiveness and treatment persistence with Ozanimod (Zeposia®) as well as quality of life in participants undergoing treatment for moderate-to-severe ulcerative colitis (UC).

NCT ID: NCT05377580 Recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.

NCT ID: NCT05370885 Recruiting - Ulcerative Colitis Clinical Trials

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Start date: May 8, 2023
Phase: Phase 2
Study type: Interventional

A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

NCT ID: NCT05369832 Recruiting - Colitis, Ulcerative Clinical Trials

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

Start date: December 16, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

NCT ID: NCT05333978 Recruiting - Crohn Disease Clinical Trials

Optoacoustic Detection of Inflammation Using MSOT Device

SCC-O-FLAME
Start date: May 31, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect inflammation in patients with chronic graft versus host disease of the skin or GI tract, Crohn's disease, or Colitis disease.

NCT ID: NCT05333471 Recruiting - Clinical trials for Chronic Granulomatous Disease-associated Colitis

Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

Start date: August 8, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Chronic granulomatous disease (CGD) weakens the body's defense against germs. CGD can also damage the colon. It can cause inflammation (colitis) that disrupts the good bacteria. Placing good bacteria from donor stool into the intestine of a person with CGD (called fecal microbiota transplantation, or FMT) may help. Objective: To see if FMT can reduce inflammation in the colon. Eligibility: People aged 10-60 who have CGD and colitis, and the treatments they have tried are not helping or have side effects. Design: Participants will have a telehealth screening visit. They will have a medical record review and medical history. They will collect stool samples at home and mail them to NIH. Participants will stay at the NIH hospital for 3-5 days. Each day, they will have the following: Physical exam Medical history and medicine review Surveys about CGD and how it affects their life Blood, stool, and urine tests Participants will have a colonoscopy. They will be sedated. A long, flexible tube will be inserted into their rectum. The tube will deliver the FMT material to their colon. Small samples of intestinal tissue will be collected. Participants may have an optional MRI of the digestive tract. Participants will have 9 follow-up telehealth visits over 6 months. They will be asked about their symptoms and side effects. They will fill out short surveys. They will collect stool and urine samples at home. Up to 2 visits can be done in person. At these visits, they may have the option to have an MRI and another colonoscopy to get more tissue samples. Participation will last for 6-7 months.

NCT ID: NCT05327790 Recruiting - Ulcerative Colitis Clinical Trials

LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

Start date: June 3, 2022
Phase: Phase 2
Study type: Interventional

To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.