Calibrated Diets and Human Intestinal Microflora

Bacteria Clinical Trial

— AlimIntest  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639561
• Other study ID #: DCIC 06 12
• Status: Completed
• Phase: N/A
• First received: March 14, 2008
• Last updated: February 16, 2009
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bacteria

Intervention

Dietary Supplement:
• 10 g of fibres per day
10 g of fibres per day
• 40 g of fibres per day
40g of fibres per day

Locations

Country	Name	City	State
France	Clinical research center	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Centre de Recherche en Nutrition Humaine Rhone-Alpe, Institut National de la Recherche Agronomique

Country where clinical trial is conducted

France, 

References & Publications (7)

Aaltonen LA, Peltomäki P, Leach FS, Sistonen P, Pylkkänen L, Mecklin JP, Järvinen H, Powell SM, Jen J, Hamilton SR, et al. Clues to the pathogenesis of familial colorectal cancer. Science. 1993 May 7;260(5109):812-6. — View Citation

Black AE, Coward WA, Cole TJ, Prentice AM. Human energy expenditure in affluent societies: an analysis of 574 doubly-labelled water measurements. Eur J Clin Nutr. 1996 Feb;50(2):72-92. — View Citation

Chinda D, Nakaji S, Fukuda S, Sakamoto J, Shimoyama T, Nakamura T, Fujisawa T, Terada A, Sugawara K. The fermentation of different dietary fibers is associated with fecal clostridia levels in men. J Nutr. 2004 Aug;134(8):1881-6. — View Citation

Moore WE, Moore LH. Intestinal floras of populations that have a high risk of colon cancer. Appl Environ Microbiol. 1995 Sep;61(9):3202-7. — View Citation

Robinson RR, Feirtag J, Slavin JL. Effects of dietary arabinogalactan on gastrointestinal and blood parameters in healthy human subjects. J Am Coll Nutr. 2001 Aug;20(4):279-85. — View Citation

Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Doré J. Direct analysis of genes encoding 16S rRNA from complex communities reveals many novel molecular species within the human gut. Appl Environ Microbiol. 1999 Nov;65(11):4799-807. — View Citation

Tuohy KM, Kolida S, Lustenberger AM, Gibson GR. The prebiotic effects of biscuits containing partially hydrolysed guar gum and fructo-oligosaccharides--a human volunteer study. Br J Nutr. 2001 Sep;86(3):341-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of the composition or of the functioning of the intestinal microflora during calibrated diets		at day 1, 4 and 5 of each diet	No
Secondary	Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets		before, between and after calibrated diets	No