The aim of this study is to explore the potential of a mix of 4 freeze-dried bifidobacteria strains from Danone collection to survive in human gastro-intestinal (GI) tract of healthy volunteers after 14 days of consumption.
To this aim, one study group of 20 healthy volunteers will consume freeze-dried strains- mix twice per day diluted in 1 glass of still water during 14 consecutive days.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Age 18-60 years.
✓. Body Mass Index (BMI) between 18.5-30.0 kg/m2.
✓. Willing to consume twice per day for at least 14 days the study product diluted in 1 glass of still water.
✓. Availability to comply with the protocol and timetable.
✓. Having regular bowel movements (on ≥6 days/week).
✓. French speaking and reading.
✓. Subject willing to adhere to the specific instructions and restrictions for the entire duration of the study.
✓. Signed (written) informed consent from participant.
Exclusion criteria
✕. Subject who used within 8 weeks prior to the screening visit or are planning to use during the conduct of this study one of the listed prohibited medications that might modify gastrointestinal function. Incidental use (1 or 2 pills/tablets) of non-steroidal anti-inflammatory drugs and aspirin is allowed, if required.
✕. Subject following special diet at the screening visit (V1), or plan for such diet during the study.
✕. Subject having any previous abdominal surgery, or plan for such surgery during the study.
✕. Subject who underwent a general anesthesia in the preceding 4 weeks before the screening visit (V1).
What they're measuring
1
Presence of alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 14 days of study product consumption in healthy adults.
Timeframe: After 14 days of study product consumption
2
Comparison of the quantity of total and alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces before and after 14 days of study product consumption in healthy adults.
Timeframe: After 14 days of study product consumption
3
Presence of alive bacteria of the provided specific strains of each of the Bifidobacterium strains in feces after 1 week of follow-up in healthy adults.
Timeframe: After 1 week of follow-up
4
Comparison of the quantity of total and alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 1 week of follow-up in healthy adults.
✕. Subject with any metabolic disease, hypertension, any inflammatory disease, any psychiatric disorder, or any gastrointestinal disorder, all these medical conditions should have been diagnosed by a physician.
✕. Subject with any known food allergy or intolerance to any of the study product components or to any potential traces.
✕. Active smoker with 7 or more cigarettes per week.
✕. Subject doing high intensity physical activity in combination with following an enhanced diet within 1 month before screening or planned during the participation of the study.