Calibrated Diets and Human Intestinal Microflora (AlimIntest)
| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2008 | ||||
| Last Updated Date | February 16, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00639561 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets [ Time Frame: before, between and after calibrated diets ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Calibrated Diets and Human Intestinal Microflora | ||||
| Official Title ICMJE | Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Bacteria | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 30 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00639561 | ||||
| Other Study ID Numbers ICMJE | DCIC 06 12 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital of Grenoble, Direction de la recherche clinique | ||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Grenoble | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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