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

Tracking Information
First Received Date ^ICMJE	December 6, 2011
Last Updated Date	December 9, 2011
Start Date ^ICMJE	March 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01487759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prebiotic Effect on Metabolites in Crohn's Disease
Official Title ^ICMJE	Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Crohn Disease
Intervention ^ICMJE	Dietary Supplement: Oligofructose enriched inulin Dietary Supplement: Maltodextrin
Study Arm (s)	Active Comparator: Prebiotic Intervention: Dietary Supplement: Oligofructose enriched inulin Placebo Comparator: Placebo Intervention: Dietary Supplement: Maltodextrin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	67
Completion Date	July 2009
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01487759
Other Study ID Numbers ^ICMJE	ML4789
Has Data Monitoring Committee	No
Responsible Party	Kristin Verbeke, Katholieke Universiteit Leuven
Study Sponsor ^ICMJE	Katholieke Universiteit Leuven
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Katholieke Universiteit Leuven
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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