Prebiotic Effect on Metabolites in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01487759
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : December 12, 2011
Information provided by (Responsible Party):
Kristin Verbeke, KU Leuven

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Oligofructose enriched inulin Dietary Supplement: Maltodextrin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients
Study Start Date : March 2008
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Inulin

Arm Intervention/treatment
Active Comparator: Prebiotic Dietary Supplement: Oligofructose enriched inulin
Placebo Comparator: Placebo Dietary Supplement: Maltodextrin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01487759

Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven

Responsible Party: Kristin Verbeke, Principal investigator, KU Leuven Identifier: NCT01487759     History of Changes
Other Study ID Numbers: ML4789
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases