NCT01487759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

First QC Date

December 6, 2011

Last Update Submit

December 9, 2011

Conditions

Crohn Disease

Study Arms (2)

Prebiotic

ACTIVE COMPARATOR
Dietary Supplement: Oligofructose enriched inulin

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin

Interventions

Oligofructose enriched inulinDIETARY_SUPPLEMENT
Prebiotic
MaltodextrinDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • crohn's disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KULeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 7, 2011

Study Start

March 1, 2008

Study Completion

July 1, 2009

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations

BE(1)