NCT00806104

Brief Summary

Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 17, 2011

Status Verified

January 1, 2011

Enrollment Period

1.3 years

First QC Date

December 9, 2008

Last Update Submit

January 14, 2011

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • rectal sensitivity

    4 weeks

Secondary Outcomes (1)

  • taxonomic composition of intestinal microbiota

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

Fructo-oligosaccharides

Dietary Supplement: Fructo-oligosaccharides

2

PLACEBO COMPARATOR

Maltodextrins

Dietary Supplement: Maltodextrins

Interventions

Fructo-oligosaccharidesDIETARY_SUPPLEMENT

Dietary supplementation for 4 weeks

1
MaltodextrinsDIETARY_SUPPLEMENT

Dietary supplementation for 4 weeks

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • IBS subjects according to Rome III criteria
  • Incomfort below or equivalent to 30mmHg during Tensostat test
  • between 18 and 60 years
  • no antibiotic treatment for the last 2 months
  • less than 20g of dietary fibres consummed per day
  • no analgesic treatment
  • no treatment for intestinal transit

You may not qualify if:

  • subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
  • excessive consumption of alcohol or tobacco
  • participating to another clinical study
  • pregnant women
  • antidepressor or anxiolytic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Vall Hebron Hospital

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

fructooligosaccharide

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Michel Dapoigny, MD, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 10, 2008

Study Start

March 1, 2009

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

January 17, 2011

Record last verified: 2011-01

Locations

FR(1)ES(1)