Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie
Bobigny, 93009, France
Completed
NCT Number: NCT01897649
Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.
NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.
Completed
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Conditions
Age range
20 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- aged 20 to 50 years,
- BMI 18 to 25 kg/m2,
- absence of known or scalable organic or psychiatric disease
- no history of chronic gastrointestinal disease
- having a bowel regularity (1-3 defecation per day, of normal consistency),
- person without medication during the study (especially laxatives, anti diarrheal) (except contraceptives in women)
- having normal laboratory hepatic and renal tests (ASAT, ALAT, GGT, urea, creatinine)
- no pregnant nor nursing women
- covered by Social Security
- negative serology for hepatitis B/C and HIV
- who signed the informed consent form
Exclusion criteria
- persons abusing drugs (laxatives, anti-diarrheal)
- person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
- person intolerant to gluten and / or allergic to wheat flour
- person in vegetarian or vegan diet
- Inclusion in another clinical study
- subjects receiving over 4,500 Euros in the last 12 months (including the present study)
- subjects presenting risk of non-compliance in the opinion of the recruiting doctor.
Treatment and study plan
Nutriose FB06
Dietary Supplement15g/day NUTRIOSE FB06
GLUCIDEX 21
Dietary Supplement15g/day GLUCIDEX 21
Primary outcomes
-
Clostridium Perfringens rate in stool
Time frame: D0 ; D14 ; D28
Secondary outcomes
-
digestive tolerance
Time frame: J0 to J28 (every day)
-
stool pH
Time frame: D0 ; D14; D28
-
total stool flora
Time frame: D0 ; D14 ; D28
-
Bacteroides rate in stool
Time frame: D0 ; D14 ; D28
-
Eubacterium rectal rate in stool
Time frame: D0 ; D14 ; D28
-
Clostridium coccoides rate in stool
Time frame: D0 ; D14 ; D28
-
Clostridium leptum rate in stool
Time frame: D0 ; D14 ; D28
-
Bifidobacteria rate in stool
Time frame: D0 ; D14 ; D28
-
Lactobacteria rate in stool
Time frame: D0 ; D14 ; D28
-
Streptococcus rate in stool
Time frame: D0 ; D14 ; D28
-
Enterococcus rate in stool
Time frame: D0 ; D14 ; D28
-
Bacteroidetes rate in stool
Time frame: D0 ; D14 ; D28
-
Actinobacteria rate in stool
Time frame: D0 ; D14; D28
-
Firmicutes rate in stool
Time frame: D0 ; D14 ; D28
-
E. Coli rate in stool
Time frame: D0 ; D14 ; D28
-
Clostridium difficile rate in stool
Time frame: D0 ; D14 ; D28
-
Faecalibacterium prausnitzii rate in stool
Time frame: D0 ; D14 ; D28
-
Clostridium difficile typa A and B rate in stool
Time frame: D0 ; D14 ; D28
-
E. Coli EIEC + EPEC (eae gene) rate in stool
Time frame: D0 ; D14 ; D28
-
Shigella + E. Coli EIEC (ipaH gene) rate in stool
Time frame: D0 ; D14 ; D28
-
Listeria Monocytogenes rate in stool
Time frame: D0 ; D14 ; D28
-
Yersinia Enterocolitica rate in stool
Time frame: D0 ; D14 ; D28
Sponsors and collaborators
Lead sponsor
Nealth Sarl
Network
Collaborators
- Roquette Freres
Registry information
Official study title
Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.
Acronym: ROQ_NUTRIFLORE
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jul 12, 2013
- Registry last updated
- Jul 12, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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