Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.

Phase 1

Completed

• Conditions: Microbiota; Dietary Fibers
• Interventions: Dietary Supplement: GLUCIDEX 21; Dietary Supplement: NUTRIOSE FB06

• Registration Number: NCT01897649
• Lead Sponsor: Nealth Sarl

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLUCIDEX	GLUCIDEX 21	gruop of volunteers fed with GLUCIDEX
NUTRIOSE	NUTRIOSE FB06	group of volunteers fed with NUTRIOSE

Primary Outcome Measures

Name	Time	Method
Clostridium Perfringens rate in stool	D0 ; D14 ; D28

Secondary Outcome Measures

Name	Time	Method
Clostridium difficile rate in stool	D0 ; D14 ; D28
stool pH	D0 ; D14; D28
Lactobacteria rate in stool	D0 ; D14 ; D28
Firmicutes rate in stool	D0 ; D14 ; D28
Faecalibacterium prausnitzii rate in stool	D0 ; D14 ; D28
Eubacterium rectal rate in stool	D0 ; D14 ; D28
Bifidobacteria rate in stool	D0 ; D14 ; D28
Streptococcus rate in stool	D0 ; D14 ; D28
digestive tolerance	J0 to J28 (every day)
total stool flora	D0 ; D14 ; D28
Clostridium coccoides rate in stool	D0 ; D14 ; D28
Shigella + E. Coli EIEC (ipaH gene) rate in stool	D0 ; D14 ; D28
Clostridium leptum rate in stool	D0 ; D14 ; D28
Bacteroidetes rate in stool	D0 ; D14 ; D28
Actinobacteria rate in stool	D0 ; D14; D28
Clostridium difficile typa A and B rate in stool	D0 ; D14 ; D28
E. Coli EIEC + EPEC (eae gene) rate in stool	D0 ; D14 ; D28
Yersinia Enterocolitica rate in stool	D0 ; D14 ; D28
Bacteroides rate in stool	D0 ; D14 ; D28
Enterococcus rate in stool	D0 ; D14 ; D28
Listeria Monocytogenes rate in stool	D0 ; D14 ; D28
E. Coli rate in stool	D0 ; D14 ; D28

Trial Locations

Locations (1)

Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie; 🇫🇷 Bobigny, France