Prebiotic Effect on Metabolites in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487759
• Other study ID #: ML4789
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: December 9, 2011
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2011
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee UZLeuven
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• Oligofructose enriched inulin

• Maltodextrin

Locations

Country	Name	City	State
Belgium	KULeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium,