Calibrated Diets and Human Intestinal Microflora (AlimIntest)

February 16, 2009 updated by: University Hospital, Grenoble

Effect of Controlled Diets on Structural and Functional Dynamic of the 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
diet composed of 10g of fibre per day
Dietary supplement: 10 g of fibres per day
10 g of fibres per day
Other Names:
  • low fibres
Experimental: B
diet composed of 40g of fibre per day
Dietary supplement: 40 g of fibres per day
40g of fibres per day
Other Names:
  • high fibres

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at day 1, 4 and 5 of each diet

Secondary Outcome Measures

Outcome Measure
Time Frame
Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets
Time Frame: before, between and after calibrated diets
before, between and after calibrated diets

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

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

Investigators

  • Principal Investigator: Eric Fontaine, MDPhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 16, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCIC 06 12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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