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Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease

NCT02193750 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-04-30

No results posted yet for this study

Summary

The investigators hypothesize that a novel method for oligosaccharide supplementation, in the form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS), will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD) in remission.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)

DIETARY_SUPPLEMENT

Moderate Oligosaccharide Group

1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)

DIETARY_SUPPLEMENT

High Oligosaccharide Group

1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)

Sponsors & Collaborators

  • The Alfred

    collaborator OTHER

  • Melbourne Health

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Brian Bressler, MD · Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda

  • Peter Gibson, MD · Department of Gastroenterology Alfred Hospital, Melbourne, Australia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Australia
  • 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 NCT02193750 on ClinicalTrials.gov