MedTrace Logo

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

NCT02093767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-05-04

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Crohn's and Colitis Canada

    collaborator OTHER

  • Beneo GmbH

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • Levinus Dieleman, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-09-30
Completion
2011-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02093767 on ClinicalTrials.gov