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Colitis clinical trials

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NCT ID: NCT05171634 Completed - Ulcerative Colitis Clinical Trials

Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)

CUDISIA
Start date: May 5, 2021
Phase: N/A
Study type: Interventional

Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.

NCT ID: NCT05084261 Completed - Ulcerative Colitis Clinical Trials

An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

SCOUT
Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.

NCT ID: NCT05082428 Completed - Ulcerative Colitis Clinical Trials

This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

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

The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.

NCT ID: NCT05061446 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Start date: September 10, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

NCT ID: NCT04990245 Completed - Ulcerative Colitis Clinical Trials

pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

APOLLO
Start date: July 1, 2020
Phase:
Study type: Observational

Background and rationale: In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized. Objectives and design: To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.

NCT ID: NCT04969679 Completed - Ulcerative Colitis Clinical Trials

Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.

Start date: March 16, 2018
Phase: Phase 4
Study type: Interventional

E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.

NCT ID: NCT04963725 Completed - Ulcerative Colitis Clinical Trials

A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice

Start date: July 18, 2021
Phase:
Study type: Observational

The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.

NCT ID: NCT04933162 Completed - Ulcerative Colitis Clinical Trials

UC Cohort - The Influence of Diet on Gut Microbiotas

Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.

NCT ID: NCT04924543 Completed - Ulcerative Colitis Clinical Trials

OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

OPTIC-IBD
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal areas in their bowel. These abnormal areas can be due to active inflammation, healed inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that people with IBD are offered periodic surveillance colonoscopy procedures to identify, characterize and where necessary remove abnormal areas or lesions from the bowel. These can be difficult to characterize correctly, which is important to make the correct endoscopic diagnosis and management plan. Technical advancements in endoscopy mean that more tools are available to identify and characterize these lesions in real time during colonoscopy. Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists") will often receive special training, both during their initial postgraduate training and through continuous professional development programs. This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterize dysplasia in IBD. The goal is to support improved decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the care and outcomes of people with IBD.

NCT ID: NCT04890262 Completed - Clinical trials for Inflammatory Bowel Diseases

A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real-World Practice

VARIETY-AUT
Start date: August 18, 2021
Phase:
Study type: Observational

Vedolizumab is a medicine that helps to reduce symptoms of IBD and the associated inflammation in the digestive system for participants with ulcerative colitis or Crohn's disease. In this study, participants with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.