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Colitis, Ulcerative clinical trials

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NCT ID: NCT03251118 Recruiting - Ulcerative Colitis Clinical Trials

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

TARGET-IBD
Start date: July 24, 2017
Phase:
Study type: Observational [Patient Registry]

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

NCT ID: NCT03221036 Recruiting - Clinical trials for Moderately to Severely Active Ulcerative Colitis

Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

Start date: August 3, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab intravenous IV as induction and maintenance treatment in Chinese participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03172000 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Detection of Helicobacter Pylori in Ulcerative Colitis Patients

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

Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.

NCT ID: NCT03151850 Recruiting - Ulcerative Colitis Clinical Trials

The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis

Start date: July 2016
Phase: N/A
Study type: Observational

We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis.

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: NCT03136419 Recruiting - Ulcerative Colitis Clinical Trials

Microbiota and Immune microEnvironment in Pouchitis

MEP1
Start date: October 31, 2016
Phase: N/A
Study type: Interventional

Microbiota and innate immunity in pouchitis: predisposing factors and modulation of the inflammation with probiotics. Around 20-25% of ulcerative colitis patients undergo restorative proctocolectomy with ileal pouch anal anastomosis. Pouchitis is an idiopathic inflammatory disease that may occur in ileal pouches. In our recent studies, we showed altered microbiota and innate immunity relationships in pouchitis. We plain to perform a double-blind, placebo-controlled trial probiotic therapy vs placebo starting at the time of ileostomy closure to evaluate the impact of microbiota that colonizes the pouch mucosa in the pathogenesis of pouchits, to determine how expression and activation status of the innate immunity system in different cell types and anatomical districts of pouch mucosa relate to microbiota population and follow-up the clinical outcome of anal pouches in light of microbiota-innate immune system interplay. Our study will include three phases: 1. analysis of the intestinal microbiota with High Throughput Sequencing Unit and anaerobes cultures 2. characterization of innate immunity with TLR, NLR, nicotinic receptors and LPMC analysis 3. assessment of microbiota and innate immune system in the ileal pouch before ileostomy closure, 2 months after ileostomy closure and after 1 year follow up.

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: 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