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

NCT02093767 | Completed

• 1 other identifier: MOP81396
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

prebiotics; Synergy1

Outcome Measures

Primary Outcomes (1)

• Number of patients who show a decrease in the Mayo score ≥ 3 but the total Mayo score remains ≥ 3.

  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.

  week 9

Secondary Outcomes (1)

• Number of patients who enter remission

  week 9

Study Arms (2)

7.5g dose Synergy1

ACTIVE COMPARATOR

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

15g Synergy1

ACTIVE COMPARATOR

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

Interventions

Synergy1 DIETARY_SUPPLEMENT

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).

15g Synergy1; 7.5g dose Synergy1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Crohn's and Colitis Canada: collaborator
• Beneo GmbH: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Levinus Dieleman, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 21, 2014
• Study Start: August 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2011
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)