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Completed

NCT Number: NCT00806104

Fructo-oligosaccharides and Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Fructo-oligosaccharides

Dietary Supplement

Dietary supplementation for 4 weeks

Maltodextrins

Dietary Supplement

Dietary supplementation for 4 weeks

Primary outcomes

  1. rectal sensitivity

    Time frame: 4 weeks

Secondary outcomes

  1. taxonomic composition of intestinal microbiota

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Beghin-Meiji

Industry

Registry information

Official study title

Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2008
Registry last updated
Jan 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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