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Ulcerative Colitis Clinical Trials

Browse current & upcoming clinical research / studies on Ulcerative Colitis. There are a total of 294 clinical trials for Ulcerative Colitis in 50 countries with 32 trials currently in the United States. 77 are either active and/or recruiting patients or have not yet been completed. Click the title of each study to get the complete details on eligibility, location & other facts about the study.

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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
September 2015 - March 2018
PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids. STUDY TREATMENTS : All patients : Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days. Combination therapy arm: Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day. Azathioprine arm: Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.
Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study type: Interventional
July 2015 - August 2017
The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis
Sponsor: Qu Biologics Inc.
Study type: Interventional
July 2015 -
The purpose of this study is to determine whether APD334 is a safe and effective treatment for ulcerative colitis.
Sponsor: Arena Pharmaceuticals
Study type: Interventional
July 2015 - April 2018
Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental models of colitis including a positive effect on maintenance of remission in adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as complementary medication in induction and maintenance therapy in pediatric patients with mild to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or corticosteroids induction treatment. Main outcome measures: Disease activity defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version 21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate associations between primary outcomes and categorical variables. Associations of continues variables with primary outcome measures will be examined using ANOVA with repeated measures. P-values <0.05 will be considered significant.
Sponsor: Schneider Children's Medical Center, Israel
Study type: Interventional
May 2015 - December 2017
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis,randomized, single blind, controlled prospective study.
Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Study type: Interventional
May 2015 - November 2019
PHASE: IV TYPE OF STUDY: With direct benefit DESCRIPTIVE: multicenter, open-label, uncontrolled trial INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score =6 and with an endoscopic sub score =2. OBJECTIVE: To determine the proportion of patients with continued clinical response (CCR) and endoscopic remission at week 108, after discontinuation or de-escalation of golimumab treatment at year 1 in the subgroup of patients in continuous clinical response (CCR) and with mucosal healing (MH) (endoscopic Mayo score of 0 or 1) at week 54. STUDY DESIGN: Induction Phase : Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg Phase I : Week 10-Week 54 • Patients with primary clinical response* : Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg) • Patients without primary clinical response* : Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines) • Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety. - Clinical response is defined as a decrease from baseline in the Mayo score =30% and =3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score =1 Phase II : Week 54-Week 108 • Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy • Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy • Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)
Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study type: Interventional
May 2015 -
The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.
Sponsor: Shanghai Jiao Tong University School of Medicine
Study type: Interventional
May 2015 - September 2018
The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).
Sponsor: Receptos, Inc.
Study type: Interventional
April 2015 - April 2016
Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.
Sponsor: Asan Medical Center
Study type: Observational
April 2015 -
This randomized, pilot phase I trial studies the side effects and safety of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis.
Sponsor: National Cancer Institute (NCI)
Study type: Interventional
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