BacteriaAlimIntestNCT00639561
Calibrated Diets and Human Intestinal Microflora
A study testing 10 g of fibres per day and 40 g of fibres per day in people with Bacteria, run by University Hospital, Grenoble at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacteria
- What is being tested?
- 10 g of fibres per day and 40 g of fibres per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18,5 and 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Bacteria
- Being tested
- 10 g of fibres per day, 40 g of fibres per day
- Keywords
- digestive system, Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 g of fibres per dayDietary supplement
Also called low fibres
10 g of fibres per day
40 g of fibres per dayDietary supplement
Also called high fibres
40g of fibres per day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | diet composed of 10g of fibre per day Receives: Dietary Supplement: 10 g of fibres per day |
| B | Experimental | diet composed of 40g of fibre per day Receives: Dietary Supplement: 40 g of fibres per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification of the composition or of the functioning of the intestinal microflora during calibrated diets
Measured: 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
Measured: before, between and after calibrated diets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BacteriaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Eric Fontaine, MDPhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639561
- Sponsor's protocol ID
- DCIC 06 12
- Acronym
- AlimIntest
- Status last verified
- Feb 2009
- First submitted
- 14 Mar 2008
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10543789Aaltonen 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.
PubMed 8484121Moore 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.
PubMed 7574628Black 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.
PubMed 8641250Robinson 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.
PubMed 11506055Tuohy 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.
PubMed 11570986Chinda 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.
PubMed 15284370
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora
- ClinicalTrials.gov ID
- NCT00639561
- Acronym / sponsor ID
- AlimIntest / DCIC 06 12
- Conditions
- Bacteria
- Keywords
- digestive system, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: 10 g of fibres per daydiet composed of 10g of fibre per day |
| B | Experimental | Dietary Supplement: 40 g of fibres per daydiet composed of 40g of fibre per day |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 18,5 and 25
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 g of fibres per dayAlso: low fibres10 g of fibres per day | Dietary supplement | A |
| 40 g of fibres per dayAlso: high fibres40g of fibres per day | Dietary supplement | B |
Primary outcome
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
1 secondary outcome
Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets
Time frame: before, between and after calibrated diets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
- Background: PubMed 10543789Suau 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.
- Background: PubMed 8484121Aaltonen 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.
- Background: PubMed 7574628Moore 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.
- Background: PubMed 8641250Black 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.
- Background: PubMed 11506055Robinson 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.
- Background: PubMed 11570986Tuohy 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.
- Background: PubMed 15284370Chinda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Fontaine, MDPhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 g of fibres per day and 40 g of fibres per day in people with Bacteria, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639561, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2009.