NCT00639561

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 17, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

March 14, 2008

Last Update Submit

February 16, 2009

Conditions

Bacteria

Keywords

digestive systemDiet

Outcome Measures

Primary Outcomes (1)

  • Modification of the composition or of the functioning of the intestinal microflora during calibrated diets

    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

    before, between and after calibrated diets

Study Arms (2)

A

EXPERIMENTAL

diet composed of 10g of fibre per day

Dietary Supplement: 10 g of fibres per day

B

EXPERIMENTAL

diet composed of 40g of fibre per day

Dietary Supplement: 40 g of fibres per day

Interventions

10 g of fibres per dayDIETARY_SUPPLEMENT

10 g of fibres per day

Also known as: low fibres
A
40 g of fibres per dayDIETARY_SUPPLEMENT

40g of fibres per day

Also known as: high fibres
B

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18,5 and 25

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical research center

Grenoble, 38000, France

Location

Related Publications (7)

  • Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Dore 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. doi: 10.1128/AEM.65.11.4799-4807.1999.

    PMID: 10543789BACKGROUND

  • Aaltonen LA, Peltomaki P, Leach FS, Sistonen P, Pylkkanen L, Mecklin JP, Jarvinen 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. doi: 10.1126/science.8484121.

    PMID: 8484121BACKGROUND

  • 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. doi: 10.1128/aem.61.9.3202-3207.1995.

    PMID: 7574628BACKGROUND

  • 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.

    PMID: 8641250BACKGROUND

  • 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. doi: 10.1080/07315724.2001.10719048.

    PMID: 11506055BACKGROUND

  • 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. doi: 10.1079/bjn2001394.

    PMID: 11570986BACKGROUND

  • 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. doi: 10.1093/jn/134.8.1881.

    PMID: 15284370BACKGROUND

Study Officials

  • Eric Fontaine, MDPhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

February 17, 2009

Record last verified: 2009-02

Locations

FR(1)