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Trial record 5 of 8 for:    "Dietary Carbohydrates" | Recruiting, Not yet recruiting, Available Studies

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 4, 2017
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Levinus Dieleman, University of Alberta

Brief Summary:

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
Ulcerative Colitis Dietary Supplement: Synergy-1 Dietary Supplement: Maltodextrin

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms
Actual Study Start Date : August 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prebiotic
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to relapse [ Time Frame: 6 months ]
    The time the relapse occurs

  2. Patient compliance [ Time Frame: 3 and 6 month ]
    This will be assessed by package counting at 3 and 6 months or at relapse

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Ulcerative colitis (UC) with confirmed diagnosis by histology and endoscopy.
  • Currently in clinical remission defined as total Mayo score of ≤ 2 and endoscopic score of 0 or 1) who have experienced at least one flare in the past 18 months.
  • On stable doses of oral 5-ASA for 2 weeks and/or a stable doses of azathioprine and/or anti-tumor necrosis factor (anti-TNF) biologics for 2 months
  • Colonic involvement of >15 cm from the anal verge.
  • Ability to give valid informed consent
  • For females of child bearing potential, a negative pregnancy test and an agreement to use appropriate birth control over the study period.

Exclusion Criteria:

  • Crohn's disease, indetermined colitis or infectious colitis.
  • Active UC, (total Mayo score of ≥ 3)
  • Taking prednisone (or steroid equivalent) within 1 month of enrollment
  • Used topical 5-ASA or steroids within 2 weeks of enrollment
  • Using immunosuppressive treatments of 6-mercaptopurine or methotrexate
  • Used antibiotics within 2 months
  • Used anti-diarreal agents with the previous 3 days
  • Pregnancy or lactation
  • Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen)
  • Active gastrointestinal infection
  • Severe psychiatric disorder
  • Not able to consent to the study.

Information from the National Library of Medicine

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


Contacts
Contact: Rosica Valcheva, PhD 780-492-0019 valcheva@ualberta.ca
Contact: Melissa Silva, MD 780-492-0019 mpsilva@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Contact: Levinus Dieleman, MD, PhD    780-492-8691    l.dieleman@ualberta.ca   
Sponsors and Collaborators
University of Alberta
University of British Columbia
Investigators
Principal Investigator: Levinus A Dieleman, MD, PhD University of Alberta

Responsible Party: Levinus Dieleman, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02865707     History of Changes
Other Study ID Numbers: Pro00041938
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Levinus Dieleman, University of Alberta:
ulcerative colitis
prebiotics
b-fructans
inulin
oligofructose
intestinal microbiota

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases