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Colitis clinical trials

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NCT ID: NCT03151525 Recruiting - Colitis, Ulcerative Clinical Trials

Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

SCILLA
Start date: May 8, 2017
Phase: Phase 4
Study type: Interventional

Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA). Each patient will be followed for 12 months.

NCT ID: NCT03110289 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: NCT03110198 Recruiting - Clinical trials for Ulcerative Colitis, Unspecified

Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis

Start date: May 2017
Phase: Phase 4
Study type: Interventional

The research aims to evaluate the efficacy and safety of that mesalazine with hydrocortisone sodium succinate for the induction of clinical remission during a 4-week double-blind treatment period in active UC (define as total Mayo score of greater than or equal to 4 and less than or equal to 10). A total of 528 patients will be randomly divided into three group, one will receive mesalazine 4g with hydrocortisone sodium succinate 100mg enema, and the other two group will respectively to receive mesalazine 4g and hydrocortisone sodium 100mg one times daily for 4 weeks. The end of the study for every patient is the improvement of main symptoms.The primary endpoint is the clinical remission after 2 and 4 weeks double-blind treatment, defined on the basis of a total Mayo score ≤ 2 points, with no subscore > 1 point. The secondary endpoint are endoscopic mucosal healing at week 2 and 4 of double-blind period, defined as an absolute subscore for endoscopy portion of the Mayo score of 0 point and the change from baseline in Quality of Life at week 4 of double-blind period based on the IBDQ.

NCT ID: NCT03101800 Recruiting - Colitis, Ulcerative Clinical Trials

Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis

Start date: December 14, 2016
Phase: Phase 3
Study type: Interventional

Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative colitis. Up to 50% are treatment failures or experience adverse events leading to treatment withdrawal. Recent evidence suggests that the combination of allopurinol and low dose azathioprine increases the proportion of treatment responders and reduce the risk of adverse events. Objectives: To evaluate the beneficial and harmful effects of low dose azathioprine and allopurinol versus standard azathioprine monotherapy in patients with ulcerative colitis.

NCT ID: NCT03096717 Recruiting - Dysplasia in IBD Clinical Trials

Dysplasia in Inflammatory Chronic Idiopathic Colitis Long-standing

Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Chronic intestinal inflammation produce dysplasia more frequently than the normal population. The therapies protect against these changes, but do not rule out dysplasia. It is not known the effect of different therapies protection.

NCT ID: NCT03091309 Recruiting - Ulcerative Colitis Clinical Trials

Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

Start date: October 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

NCT ID: NCT03063957 Recruiting - Clinical trials for Colitis, Microscopic

Identification/Characterization of Changes in Microscopic Colitis

Start date: June 30, 2015
Phase:
Study type: Observational

The goal of this study is to establish a prospective observational cohort of adult patients with microscopic colitis and collect clinical information and specimens over the course of their treatment. This information will be used in order to establish a patient registry with detailed clinical data and a specimen repository for future research as well as to specifically identify genetic and molecular characteristics associated with microscopic colitis.

NCT ID: NCT03016780 Recruiting - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation for Ulcerative Colitis

FMTFUC
Start date: July 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease,but the efficacy of ulcerative colitis by fecal microbiota transplantation needs to be further explored.

NCT ID: NCT02998112 Recruiting - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

Start date: December 2016
Phase: Phase 4
Study type: Interventional

To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

NCT ID: NCT02910245 Recruiting - Colitis, Ulcerative Clinical Trials

Mercaptopurine Therapy in Ulcerative Colitis

OPTIC
Start date: November 2016
Phase: Phase 3
Study type: Interventional

This project is a double-blind, randomized, placebo-controlled, multicenter trial in the Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized 6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM) will be performed in order to optimize treatment outcomes and objective endoscopic endpoints will be used.