Prebiotic Effect on Metabolites in Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Oligofructose enriched inulin
Maltodextrin
Sponsored by
About this trial
This is an interventional basic science trial for Crohn Disease
Eligibility 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
Sites / Locations
- KULeuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prebiotic
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01487759
Brief Title
Prebiotic Effect on Metabolites in Crohn's Disease
Official Title
Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prebiotic
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligofructose enriched inulin
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
KULeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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Prebiotic Effect on Metabolites in Crohn's Disease
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