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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
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 6, 2011
Last Updated
December 9, 2011
Sponsor
KU Leuven
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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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