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Completed

NCT Number: NCT00639561

Calibrated Diets and Human Intestinal Microflora

The main objective of the study is to realized a collection of feces in order to study the modification of the intestinal microflora according to alimentary fibres

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical research center

Grenoble, 38000, France

About this study

Human intestinal tract count up to 1014 bacteria. We consider that each bacterial flora is composed of more than 500 different species among which only 20% are cultivable. Although this flora is well unknown, it is known that it play a major role in the metabolism of the eating fibers. Dysfunctions of this flora may be implied in numerous local and general pathologies.

It has been shown that probiotics and prebiotics are able to act upon the intestinal flora. On the basis of the personal real-life, it is generally considered acquired that our diet modifies this flora. However not many studies have validated this hypothesis with human normal diet (not artificially enriched with prebiotics or probiotics). The idea that our diet can modified the functioning of our intestinal flora (and so favor certain pathologies or activate recovery) is widely hypothetic.

A best knowledge of the diversity of this flora and to put at disposal tools to study it on a large scale could allow to answer this question. The demonstration that some food components could modify the composition or the functioning of this flora would have considerable consequences in medicine and food processing industry.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI between 18,5 and 25

Exclusion criteria

  • Antibiotherapy in the previous month
  • Current Antibiotherapy
  • Gastro-intestinal dysfunction
  • Pregnancy, parturient and feeding woman
  • Person deprived of freedom by judiciary or administrative decision, person in legal protection,
  • Prebiotic and/or osmotic laxatives in the previous month
  • Preparation for coloscopy in the previous month

Treatment and study plan

10 g of fibres per day

Dietary Supplement

10 g of fibres per day

Other names: low fibres

40 g of fibres per day

Dietary Supplement

40g of fibres per day

Other names: high fibres

Primary outcomes

  1. Modification of the composition or of the functioning of the intestinal microflora during calibrated diets

    Time frame: at day 1, 4 and 5 of each diet

Secondary outcomes

  1. Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets

    Time frame: before, between and after calibrated diets

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Centre de Recherche en Nutrition Humaine Rhone-Alpe
  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Registry information

Official study title

Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora

Acronym: AlimIntest

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 20, 2008
Registry last updated
Feb 17, 2009

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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