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Ulcerative Colitis clinical trials

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NCT ID: NCT05225545 Recruiting - Ulcerative Colitis Clinical Trials

Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis

Start date: November 4, 2019
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.

NCT ID: NCT05218850 Recruiting - Ulcerative Colitis Clinical Trials

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

Start date: June 29, 2022
Phase: Phase 1
Study type: Interventional

Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.

NCT ID: NCT05213234 Recruiting - Ulcerative Colitis Clinical Trials

Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

Start date: July 9, 2021
Phase: N/A
Study type: Interventional

The hypothesis of this study is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels. All subjects will be randomized to once daily 5-ASA medications at two different times of the day: between 06:00 - 10:00 h or 18:00 - 22:00 h. Three disease assessments will performed at: 1) enrollment just before randomization; 2) month 3, at the completion of first arm (Condition 1), and 3) month 6, after completion of the second arm (Condition 2). During these study time points, participants will be asked to complete questionnaires, track their 5-ASA medication usage, provide a stool sample, blood draw, urine test, wear a watch to measure sleep patterns, and complete a flexible sigmoidoscopy.

NCT ID: NCT05205603 Recruiting - Ulcerative Colitis Clinical Trials

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Start date: January 15, 2022
Phase: Phase 4
Study type: Interventional

Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.

NCT ID: NCT05186623 Recruiting - Ulcerative Colitis Clinical Trials

Prediction Model for Response to Biologics and Small Molecular Agent for UC

Start date: February 5, 2022
Phase:
Study type: Observational [Patient Registry]

This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis.

NCT ID: NCT05181137 Recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.

NCT ID: NCT05180175 Recruiting - Ulcerative Colitis Clinical Trials

The Nordic IBD Treatment Strategy Trial

NORDTREAT
Start date: February 7, 2022
Phase: Phase 4
Study type: Interventional

Purpose: To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes. Objectives: Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. Secondary objective: To assess if a top-down treatment can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis. Study design: A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD patients are randomised (1:1) to a group with access to the protein signature or a group without access to the protein signature. Study subjects within the protein signature arm who display a high-risk protein profile, will be treated according to a top-down treatment algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to the protein signature will be treated according to current clinical practice. Study population: Newly diagnosed IBD patients. Number of subjects:250 Primary variables: Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure. Ulcerative colitis; - Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0. - Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g Crohn's disease; - Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline. - Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g.

NCT ID: NCT05176366 Recruiting - Ulcerative Colitis Clinical Trials

Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis

Start date: December 19, 2022
Phase: Phase 1
Study type: Interventional

Protocol Summary - Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory ulcerative colitis. - Short Title: ExoFlo for ulcerative colitis - Phase: 1 - Methodology: Open label - Study Duration: 24 months - Subject Participation: 58 weeks - Single or Multi-Site: Multi-Site

NCT ID: NCT05118919 Recruiting - Ulcerative Colitis Clinical Trials

A Safety Study of Lactobacillus Reuteri BGP-014 in Patients With Ulcerative Colitis

Start date: February 9, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of Lactobacillus reuteri BGP-014 in mild to moderate active Ulcerative Colitis (UC) patients as an oral administered local treatment in addition to Standard of Care (SoC) treatment.

NCT ID: NCT05069259 Recruiting - Ulcerative Colitis Clinical Trials

Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.

KIC-START
Start date: March 28, 2022
Phase:
Study type: Observational

This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis. Conventional clinical outcomes will give a better understanding of response and remission rates in a representative, post-marketing population. Regular patient questionnaires and measurement of a biomarker of gut inflammation will provide detail on how patients experience induction treatment and contextualise the efficacy data.