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Prebiotic Effect on Metabolites in Crohn's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487759
First Posted: December 7, 2011
Last Update Posted: December 12, 2011
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.
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven
  Purpose
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 Intervention
Crohn Disease Dietary Supplement: Oligofructose enriched inulin Dietary Supplement: Maltodextrin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kristin Verbeke, Katholieke Universiteit Leuven:

Enrollment: 67
Study Start Date: March 2008
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
Active Comparator: Prebiotic Dietary Supplement: Oligofructose enriched inulin
Placebo Comparator: Placebo Dietary Supplement: Maltodextrin

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01487759


Locations
Belgium
KULeuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
  More Information

Responsible Party: Kristin Verbeke, Principal investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01487759     History of Changes
Other Study ID Numbers: ML4789
First Submitted: December 6, 2011
First Posted: December 7, 2011
Last Update Posted: December 12, 2011
Last Verified: December 2011

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