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Prebiotic Effect on Metabolites in Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristin Verbeke, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01487759
First received: December 6, 2011
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Inulin
U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487759

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

No publications provided

Responsible Party: Kristin Verbeke, Principal investigator, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01487759     History of Changes
Other Study ID Numbers: ML4789
Study First Received: December 6, 2011
Last Updated: December 9, 2011
Health Authority: Belgium: Ethics Committee UZLeuven

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

ClinicalTrials.gov processed this record on May 23, 2013