The effects of daily supplementation of the NUTRIOSE® on the fecal microbiota. The hypothesis of the study is that the NUTRIOSE® is able to modulate the intestinal microbiota in a positive way, compare to a placebo, in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
124
After randomization (V2 visit), the subjects will consume per os, from V2 to V3, 1 sachet of 15g per day, in the morning, of active formula (NUTRIOSE®) during 4 weeks. They will consume 1 sachet in the morning. Powder will have to be mixed with usual beverage of the subject (whatever the type of drink, cold or hot).
After randomization (V2 visit), the subjects will consume per os, from V2 to V3, 1 sachet of 15g per day, in the morning, of placebo during 4 weeks. They will consume 1 sachet in the morning. Powder will have to be mixed with usual beverage of the subject (whatever the type of drink, cold or hot).
Clinical Investigation Unit of Biofortis Paris
Paris, France
Clinical Investigation Unit of Biofortis
Saint-Herblain, France
Comparison at V3 of relative abundance of Parabacteroides genus in intestinal microbiota
Assessed via Shotgun metagenomics analysis
Time frame: 4 weeks
Comparison at V4 of relative abundance of Parabacteroides genus in intestinal microbiota.
Assessed via Shotgun metagenomics analysis
Time frame: 7 or 8 weeks
Comparisons at V3 and V4 of relative abundance of intestinal microbiota (Bacterial species of Parabacteroides genus, Bacteroides genus, Firmicutes phylum, the functional levels of the intestinal microbiota, ...)
Assessed via Shotgun metagenomics analysis
Time frame: 2 weeks
Comparisons at V3 and V4 of intestinal parameters : Fecal pH
Assessed via laboratory analyse (no unit)
Time frame: 2 weeks
Comparisons at V3 and V4 of intestinal parameters: Fecal short chain fatty acids (SCFA)
Assessed via laboratory analyse (µmol/g)
Time frame: 2 weeks
Comparisons at V3 and V4 of intestinal parameters: Secretory immunoglobulin A in feces
Assessed via laboratory analyse (mg/g)
Time frame: 2 weeks
The frequency of adverse events
Treatment-Emergent Adverse Events (TEAE), Serious treatment-emergent adverse events (STEAE), TEAEs leading to Investigational Product (IP) discontinuation, Treatment-Emergent Adverse Reaction (TEAR) and gastro-intestinal TEAE.
Time frame: 7 or 8 weeks
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