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Prebiotic Effect on Metabolites in Crohn's Disease

NCT ID: NCT01487759

Last Updated: 2011-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Prebiotic

Group Type ACTIVE_COMPARATOR

Oligofructose enriched inulin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oligofructose enriched inulin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Kristin Verbeke

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KULeuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML4789

Identifier Type: -

Identifier Source: org_study_id