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Calibrated Diets and Human Intestinal Microflora (AlimIntest)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00639561
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : February 17, 2009
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment
Bacteria Dietary Supplement: 10 g of fibres per day Dietary Supplement: 40 g of fibres per day

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora
Study Start Date : February 2008
Primary Completion Date : July 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: high fibres

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets [ Time Frame: before, between and after calibrated diets ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639561

Clinical research center
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Institut National de la Recherche Agronomique
Principal Investigator: Eric Fontaine, MDPhD University Hospital, Grenoble
More Information

Responsible Party: University Hospital of Grenoble, Direction de la recherche clinique
ClinicalTrials.gov Identifier: NCT00639561     History of Changes
Other Study ID Numbers: DCIC 06 12
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

Keywords provided by University Hospital, Grenoble:
digestive system