Prebiotic Effect on Metabolites in Crohn's Disease

December 9, 2011 updated by: Kristin Verbeke, KU Leuven

Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients

The purpose of this study is to investigate the influence of the prebiotic oligofructose enriched inulin on the metabolite pattern in Crohn's disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KULeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • crohn's disease

Exclusion Criteria:

  • severe crohn's disease (harvey bradshaw index >12)
  • pregnancy
  • history of colectomy
  • use of antibiotics 4-wks before start of the study
  • use of sulfapyridine
  • use of commercially available prebiotics and probiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Maltodextrin
Active Comparator: Prebiotic
Dietary supplement: Oligofructose enriched inulin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Study Completion

July 1, 2009

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 7, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2011

Last Update Submitted That Met QC Criteria

December 9, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML4789

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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