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 range
45 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects aged between 45 and 60 years old.
. BMI between 18.5 kg/m2 and 30 kg/m2.
. Subjects who are overtly healthy as determined by the investigator.
. Willing and/or able to:
. Willing to limit alcohol consumption and not to smoke or consume any soft or hard drug during the study.
. Having access to adequate space to store the investigational products in their own fridge at home.
. Having regular bowel movements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Signed written informed consent by the participant.
Exclusion criteria
. 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.
. Known allergy or intolerance to any ingredients or potential allergens.
. Pregnancy or breast-feeding at the screening visit or plan for pregnancy during the study.
. 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.
. Unable (or unwilling) to adhere to protocol requirements (based on investigator's judgement).
. Subject with a special diet at the screening visit, or plan for such diet during the study.
. Major changes in subject's dietary habits ≤ 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.
. Enhanced diet together with intense physical activity ≤ 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.