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

Nealth Sarl60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Microbiota Dietary Fibers

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes