Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees)
France182 participantsStarted 2025-02-21
Plain-language summary
Bifidobacterium strains with potential health benefits can contribute to the gastrointestinal wellbeing. However, the ability of these strains to survive gastro-intestinal tract stress and their impact on gut microbiome remains to be clarified. Moreover, prebiotic fibres, such as galacto-oligosaccharides (GOS) can promote the proliferation of Bifidobacteria. This is why the current study aims to assess the impact of Bifidobacteria consumption on human gut microbiome with or without GOS compared to control product.
Who can participate
Age range45 Years ā 60 Years
SexALL
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Inclusion criteria
ā. Male and female subjects aged between 45 and 60 years old.
ā. BMI between 18.5 kg/m2 and 30 kg/m2.
ā. Subjects who are overtly healthy as determined by the investigator.
ā. Willing and/or able to:
ā. Willing to limit alcohol consumption and not to smoke or consume any soft or hard drug during the study.
ā. Having access to adequate space to store the investigational products in their own fridge at home.
ā. Having regular bowel movements.
ā. Signed written informed consent by the participant.
Exclusion criteria
ā. Any ongoing metabolic disease, hypertension, inflammatory disease, allergic conditions requiring chronic systemic medication, psychiatric disorder, gastrointestinal disorder, chronic pain, or neurological disorder diagnosed by a physician.
ā. Known allergy or intolerance to any ingredients or potential allergens.
ā. Pregnancy or breast-feeding at the screening visit or plan for pregnancy during the study.
ā. Any antecedents or plan for digestive or dental surgery, general anaesthesia or any participation in another study with investigational or marketed products potentially affecting the gut microbiota.
What they're measuring
1
The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species.
Timeframe: After 28 days of study product consumption
ā. Unable (or unwilling) to adhere to protocol requirements (based on investigator's judgement).
ā. Subject with a special diet at the screening visit, or plan for such diet during the study.
ā. Major changes in subject's dietary habits ā¤ 4 weeks before the screening visit or plan for such major changes during the study including change in vitamin or mineral supplements use, but except for dietary restrictions related to the study.
ā. Enhanced diet together with intense physical activity ā¤ 4 weeks before the screening visit, plan for such a diet and training during the study, or plan for major changes in physical activity during the study.