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Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Crohn's and Colitis Canada
Beneo GmbH
Information provided by (Responsible Party):
Levinus Dieleman, University of Alberta
ClinicalTrials.gov Identifier:
NCT02093767
First received: March 19, 2014
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
Based on the efficacy of inulin and oligofructose in treating experimental colitis and emerging evidence suggesting probiotics are efficacious in maintaining and inducing remission in human ulcerative colitis (UC), the investigators intend to conduct an open label study using Synergy-1, a 1:1 oligosaccharide/ inulin mixture, in patients with mild to moderately active left-sided UC. The investigators hypothesize that oligofructose-enriched inulin (Synergy-1) can be used safely in the treatment of mild to moderate UC, and daily oral administration of Synergy-1 will result in the clinical improvement and/ or remission of disease. Subjects will be randomized to either a 7.5g or 15g dose of Synergy-1 in order to investigate what amount of the prebiotic is efficacious and tolerable in patients with active UC. The clinical activity of disease will be evaluated using endoscopy and symptom scores. The investigators will also study the effect Synergy-1 on mucosal histology, intestinal microbiota composition and function and markers of inflammation (e.g. fecal calprotectin, cytokines). The study will be for 9 weeks from baseline wherein all subjects will receive Synergy-1 treatment. Half the subjects will receive a dose of 7.5g and half will receive 15g daily.

Condition Intervention
Ulcerative Colitis Dietary Supplement: Synergy1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open-Label Trial of a Prebiotic Preparation Containing Inulin and Oligofructose (Synergy-1) for the Treatment of Mild to Moderate Acute Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Levinus Dieleman, University of Alberta:

Primary Outcome Measures:
  • Number of patients who show a decrease in the Mayo score ≥ 3 but the total Mayo score remains ≥ 3. [ Time Frame: week 9 ]
    Mayo score is a total of bowel frequency, rectal bleeding, endoscopic score and physician's rating of severity, each of the parameters on the scale 0-3.


Secondary Outcome Measures:
  • Number of patients who enter remission [ Time Frame: week 9 ]
    Clinical and endoscopic remission is defined as a score of 0 in the rectal bleeding and stool frequency parts of the Mayo together with a score of 0 or 1 in the sigmoidoscopic portion of the Mayo. The total Mayo score must not be greater than 2.


Enrollment: 24
Study Start Date: August 2007
Study Completion Date: December 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 7.5g dose Synergy1
7.5 g/day dose of Synergy1 (oligofructose enriched inulin 1:1) for 9 weeks. The daily dose is dispersed in two sachets of 3.75 g each which are consumed at breakfast and dinner
Dietary Supplement: Synergy1
The prebiotic preparation, Synergy-1, consists of 1:1 inulin and oligosaccharide. The chicory derived inulin has a degree of polymerization (DP) of 10 to 60 (average DP of 25). The oligofructose is produced by partial enzymatic hydrolysis of chicory derived inulin and has a DP ranging between 3 and 7 (average DP of 4).
Active Comparator: 15g Synergy1
15 g/day dose of Synergy1 (oligofructose enriched inulin 1:1) for 9 weeks. The daily dose is dispersed in two sachets of 7.5 g each which are consumed at breakfast and dinner
Dietary Supplement: Synergy1
The prebiotic preparation, Synergy-1, consists of 1:1 inulin and oligosaccharide. The chicory derived inulin has a degree of polymerization (DP) of 10 to 60 (average DP of 25). The oligofructose is produced by partial enzymatic hydrolysis of chicory derived inulin and has a DP ranging between 3 and 7 (average DP of 4).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18 - 65 years of age.
  • Diagnosis of ulcerative colitis established by previous endoscopies, with histology and clinical course consistent with diagnosis.
  • Colitis must extend for more than 15 cm above the anal verge, and involve at least the rectosigmoid.
  • Mild to moderately active ulcerative colitis defined by a minimum score of 3 and a maximum score of 8 on the 12 point Mayo scale. Mayo scores are assigned by (1) stool frequency, (2) rectal bleeding, (3) endoscopic findings and (4) physician's overall assessment of disease severity
  • At least one previous episode of ulcerative colitis, prior to the current episode
  • Duration of current symptomatic episode less than 4 weeks.
  • Ability to give valid informed consent.
  • For females of childbearing potential, a negative pregnancy test.

Exclusion Criteria:

  • Crohn's disease or pouchitis.
  • Current infectious enteritis.
  • Use of oral steroids within the last 4 weeks of the screening visit.
  • Use of antibiotics within the last 2 weeks of the screening visit
  • Change in dose of oral 5-ASA products within the last 2 weeks of the screening visit.
  • Topical 5-ASA or steroids within 7 days prior to the baseline endoscopy
  • Use of immunosuppressive or biological agent within 3 months of screening.
  • Use of NSAIDS one week before screening.
  • Use of anti-diarrheal drugs within the last 1 week of the screening visit.
  • Use of probiotic preparations either prescribed or over-the-counter within two weeks of screening.
  • Use of natural health products within 2 weeks of screening (except multivitamins and minerals)
  • Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the investigator
  • Imminent need for colectomy
  • Presence of severe UC (defined as a Mayo of 9 or greater)
  • Pregnancy or lactation
  • Inability to give a valid informed consent or to properly comply with study procedures for any reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02093767

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Crohn's and Colitis Canada
Beneo GmbH
Investigators
Principal Investigator: Levinus Dieleman, PhD University of Alberta
  More Information

Responsible Party: Levinus Dieleman, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02093767     History of Changes
Other Study ID Numbers: MOP81396
Study First Received: March 19, 2014
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Levinus Dieleman, University of Alberta:
prebiotics
Synergy1

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

ClinicalTrials.gov processed this record on September 21, 2017