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Ulcerative Colitis clinical trials

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NCT ID: NCT02895100 Terminated - Ulcerative Colitis Clinical Trials

Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).

NCT ID: NCT02878083 Terminated - ULCERATIVE COLITIS Clinical Trials

Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

DETECT
Start date: January 11, 2017
Phase: N/A
Study type: Interventional

The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine. This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.

NCT ID: NCT02864264 Terminated - Healthy Volunteers Clinical Trials

Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

Start date: September 14, 2016
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.

NCT ID: NCT02849951 Terminated - Ulcerative Colitis Clinical Trials

A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

PROTECT-3
Start date: July 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine

NCT ID: NCT02808390 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

SEGMENT
Start date: November 28, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

NCT ID: NCT02734589 Terminated - Ulcerative Colitis Clinical Trials

Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.

NCT ID: NCT02579733 Terminated - Ulcerative Colitis Clinical Trials

Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

ACE
Start date: February 1, 2016
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.

NCT ID: NCT02520284 Terminated - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis

Start date: September 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the efficacy of andecaliximab to maintain EBS clinical remission at Week 52 (Cohort 2); and 3) To evaluate the safety and tolerability of andecaliximab. The study will consist of 3 parts: Induction Phase (Cohort 1), Maintenance Phase (Cohort 2), and an optional Extended Treatment Phase.

NCT ID: NCT02488954 Terminated - Ulcerative Colitis Clinical Trials

Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis

EMMENTAL
Start date: February 12, 2016
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation. Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.

NCT ID: NCT02481687 Terminated - Ulcerative Colitis Clinical Trials

The Value of I-Scan and Confocal Laser Endomicroscopy for the Assessment of Chronic Inflammatory Bowel Disease

I-Scan-CLE-IBD
Start date: June 2015
Phase: N/A
Study type: Observational

Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.