Ulcerative Colitis Relapse Prevention by Prebiotics
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|ClinicalTrials.gov Identifier: NCT02865707|
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : May 21, 2019
Ulcerative colitis (UC) is a relapsing chronic intestinal inflammation with no existing cure, that affects over 300 per 100.000 Canadians, the highest prevalence in the world. The standard drug therapies are expensive and potentially toxic, and mostly directed against the chronic inflammatory process. UC is the result of a dysbiosis between disease-inducing and protective intestinal bacteria in a genetically susceptible host. Non-digestible dietary carbohydrates (NDC) stimulate the growth of protective endogenous intestinal bacteria which ferment them into short-chain fatty acids (SCFA), some of the latter with natural anti-inflammatory properties, and are called prebiotics. The investigator was the first to report that oral intake of NDC, the dietary β-fructans inulin plus fructo-oligosaccharides (FOS), reduced colitis in a genetically-induced rat colitis model. Both inulin and FOS reduced colitis, each NDC modifying specific luminal microbiota. A small trial with the same mixture of NDC in patients with active UC relapsing on oral 5-aminosalicylic acid (5-ASA) showed a dose-dependent clinical response, confirming the translational potential of this NDC mixture.
The investigators propose a randomized placebo-controlled trial to assess if inulin plus FOS can also prevent such relapses in UC patients with inactive disease on stable maintenance drugs. Primary hypothesis is that inulin plus FOS is effective adjunct therapy to standard drugs for maintaining clinical remission. The second hypothesis is that the colonic microflora and its metabolic function, altered by inulin plus FOS, or not, mediate protection or relapse in UC. The longitudinal design of this maintenance prevention study and by serially collecting colon biopsies, stool, serum and urine within the same patient before a relapse (inflammation) occurs, would enable to identify unique changes in the intestinal microbiota, their metabolic functions and also assess effects on host-immune response that are associated with remission or before a relapse occurs during treatment with beta-fructans, or not.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Dietary Supplement: Synergy-1 Dietary Supplement: Maltodextrin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2020|
Prebiotic group will take 15 grams of prebiotic product Synergy-1 per day for 6 months. Synergy-1 is chicory-derived β-fructans inulin plus FOS (1:1). During the first two weeks the patient is advised to take 7.5 g of the product at breakfast only. Starting in week 3 until the end of the treatment the participant will take 7.5 g at breakfast and 7.5 g at dinner for a total of 6 months, or until you experience a flare.
Dietary Supplement: Synergy-1
Synergy-1 is chicory-derived β-fructans inulin plus FOS (1:1).
Placebo Comparator: Placebo
Placebo group will take 15 grams of maltodextrin per day for 6 months. Maltodextrin is a sugar adsorbed in the small bowel with no effect on the colonic intestinal microbiota. During the first two weeks the patient is advised to take 7.5 g of the product at breakfast only. Starting in week 3 until the end of the treatment the participant will take 7.5 g at breakfast and 7.5 g at dinner for a total of 6 months, or until you experience a flare.
Dietary Supplement: Maltodextrin
Maltodextrin is carbohydrate adsorbed in the small bowel.
- Prevention of relapse [ Time Frame: 6 months ]The percentage of patients that experienced relapse during the treatment period in prebiotic group versus that in the placebo group. Percentage will be calculated using the number of patients that relapse divided to the total number of patients in the treatment group. Relapse is defined as an total Mayo score of 3 or more with an endoscopy grade equal to or more than 2, and rectal bleeding for at least 3 days.
- Time to relapse [ Time Frame: 6 months ]The time the relapse occurs
- Patient compliance [ Time Frame: 3 and 6 month ]This will be assessed by package counting at 3 and 6 months or at relapse
- Patient tolerability [ Time Frame: 3 and 6 month ]The number of patients that experience adverse events related to treatment. This will be assessed by structured questionnaire at 3 and 6 months or at relapse
- Changes in endoscopic disease activity inflammation [ Time Frame: 0 and 6 month ]Endoscopic disease activity will be determined during sigmoidoscopy at baseline and 6 month or at relapse
- Changes in fecal calprotectin [ Time Frame: 0, 1, 3 and 6 month ]Mucosal inflammation will be determined by fecal calprotectin concentration at baseline and at months 1, 3 and 6 or during relapse
- Changes in Mayo score [ Time Frame: 0 and 6 month ]Total Mayo score will be determined at baseline and at 6 months of treatment, or during a relapse.
- Changes in microscopic score in colonic biopsies [ Time Frame: 0 and 6 months ]Biopsies collected during the sigmoidoscopy procedure at baseline and at month 6 or at relapse will be used in histology analysis to determine the degree of microscopic inflammation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865707
|Contact: Rosica Valcheva, PhDfirstname.lastname@example.org|
|Contact: Melissa Silva, MDemail@example.com|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2E1|
|Contact: Levinus Dieleman, MD, PhD 780-492-8691 firstname.lastname@example.org|
|Principal Investigator:||Levinus A Dieleman, MD, PhD||University of Alberta|