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Ulcerative Colitis clinical trials

View clinical trials related to Ulcerative Colitis.

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NCT ID: NCT03124121 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels

GO-LEVEL
Start date: July 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC). Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

NCT ID: NCT03110289 Not yet recruiting - Ulcerative Colitis Clinical Trials

Restoration of the Microbiome Through Superdonor Selection

RESTORE-UC
Start date: April 30, 2017
Phase: N/A
Study type: Interventional

The AIM of this study is to investigate whether the FMT success rate in active UC patients can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by repeated FMT. The investigators will start a national multi-centre double-blind randomized sham-controlled trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score 2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor' faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham). Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be derived from one donor. Donors will be pre-selected based on a species richness and abundance of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different time points. 16S rRNA stool analysis will be performed to assess the microbial changes after FMT.

NCT ID: NCT03104036 Recruiting - Ulcerative Colitis Clinical Trials

Faecal Bacteriotherapy for Ulcerative Colitis

FACTU
Start date: April 2017
Phase: Phase 2
Study type: Interventional

The etiopathogenesis of ulcerative colitis (UC) is not fully understood. One of the theories of UC pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. Potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (FMT). Review of the literature on FMT suggests great potential as the treatment for UC, but two prospective controlled study that has been published yet are inconsistent. The first objective of the project is to compare the administration of FMT enema with mesalazine enema for inducing remission in patients with active left-sided UC in the form of a prospective, randomized, controlled study. The second objective is to observe changes in the intestinal microbiota during and after FMT focusing on bacterial DNA sequencing to identify the bacterial species which are responsible for the effect of the FMT.

NCT ID: NCT03093259 Not yet recruiting - Ulcerative Colitis Clinical Trials

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Start date: July 1, 2017
Phase: Phase 2
Study type: Interventional

This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 150 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

NCT ID: NCT03091309 Not yet recruiting - Ulcerative Colitis Clinical Trials

Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Inflammatory Bowel Disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that comprises two subtypes, Crohn's disease (CD) and Ulcerative Colitis (UC). Because the risk of IBD is greatest during the third decade of life, its impact for women is during the reproductive years. Women with inflammatory bowel disease are at a 2-fold higher risk of adverse outcomes during pregnancy as compared to the general population. Pregnancy is an especially vulnerable time for women with IBD, and out of misguided concerns that medications may confer unnecessary harms to their fetus, many women often stop taking life savings medications; without realizing that this sub-optimal adherence could actually lead to life threatening complications for them and their fetus. Counseling pregnant women with IBD is therefore an important step in improving medication adherence. The investigators hypothesize that counseling sessions with an IBD nurse that incorporates motivational interviewing and telemedicine-based follow-up sessions tailored to individual needs will improve medication adherence and pregnancy outcomes. The following specific aims are to be addressed by this multi-center randomized clinical trial comparing individual nurse-based counseling to standard of care: Specific Aim #1: To assess whether patient-centered counseling incorporating motivational interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication adherence during pregnancy and pregnancy outcomes Specific Aim #2: To validate the use of self-reported medication adherence during pregnancy in the IBD population Specific Aim #3: To compare healthcare utilization and its associated economic impact between intervention and control groups during pregnancy and in the 12 months following delivery

NCT ID: NCT03079700 Completed - Ulcerative Colitis Clinical Trials

Immune Modulation From Trichuris Suis

Start date: August 1, 2012
Phase: N/A
Study type: Observational

Mucosal immunology during helminth infection

NCT ID: NCT03074656 Recruiting - Clinical trials for Rheumatoid Arthritis

The Norwegian Drug Monitoring Study

NOR-DRUM
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Infliximab and other TNF-inhibitors have revolutionised the treatment of several immunological inflammatory diseases. Still, more than half of the patients either do not respond sufficiently to infliximab therapy or loose efficacy over time. The large individual variation in the serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be main reasons for these treatment failures. An individualised treatment strategy based on systematic assessments of serum drug concentrations, therapeutic drug monitoring, has been proposed as a clinical tool to optimise efficacy of infliximab treatment. Therapeutic drug monitoring seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy still remain to be shown. The NOR-DRUM study is planned as a national, randomised controlled multicentre trial in two parts aiming to assess the effectiveness of therapeutic drug monitoring in order to achieve remission in patients with immunological inflammatory diseases starting infliximab treatment (part A) and in order to maintain disease control in patients on maintenance infliximab treatment (part B). The results of the NOR-DRUM study will hopefully contribute to an implementation of a personalised medicine approach to treatment with infliximab and other biological drugs.

NCT ID: NCT03071081 Recruiting - Ulcerative Colitis Clinical Trials

Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects

Start date: February 8, 2017
Phase: Phase 1
Study type: Interventional

This study evaluates the safety and tolerability of TOP1288 oral single ascending and multiple doses in healthy subjects.

NCT ID: NCT03059849 Not yet recruiting - Ulcerative Colitis Clinical Trials

Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

BEAT-IBD
Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.

NCT ID: NCT03053713 Recruiting - Ulcerative Colitis Clinical Trials

The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.