Clinical trial Recruiting at 1 site Interventional Ages 45 to 60

Fermented dairy product and bifidobacteria diversity in adults

Official title: A Randomised, Controlled, Double-blind, Parallel Groups, Single-centre Study to Assess the Bifidobacterium Diversity After 28-days Consumption of a Fermented Dairy Product With Three Bifidobacterium Strains Compared to Yoghurt in 45 to 60-year-old Healthy Subjects

Run by Danone Global Research & Innovation Center · NCT07700381 · Data updated 2026-11-12

This study tests whether consuming a fermented dairy product changes gut bacteria diversity in healthy adults aged 45–60 compared with a control product.

Quick facts

Study typeInterventional
Ages45 Years to 60 Years
SexAll
Enrollment115 (estimated)
SponsorDanone Global Research & Innovation Center
Industry-sponsored
Locations1 site (Dijon)
StatusRecruiting
StartedAugust 26, 2026
Main results expectedDecember 2026
Study endsJanuary 2027
Registry record updatedAugust 28, 2026
Trial IDNCT07700381 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 45–60 who are currently healthy, speak French, and can comply with twice-daily product intake and sample collection.

Probably not a fit

Individuals with health conditions, recent antibiotic use, or those unable to adhere to the dietary restrictions may experience limited or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adults aged 45–60 will consume either a fermented dairy product containing specific bifidobacteria or a control product for 28 days. The study will measure changes in the gut microbiome and assess how well bifidobacteria survive gastrointestinal conditions under real-life use. Participants will provide fecal samples and complete the program while restricting other probiotics and fermented dairy foods. The design is a constrained, two-arm, parallel comparison using self-collected samples and close dietary monitoring. No clinical outcomes are being tested beyond microbiome composition and related gut health markers.

Why it matters

Potential benefit: If successful, the study could clarify how a bifidobacteria-containing product influences gut microbiome diversity in middle-aged adults.

How similar studies have gone: Previous work suggests dietary bifidobacteria can affect gut microbiota, but results vary and this study explores a specific fermented product in a defined age group.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Male and female subjects aged between 45 and 60 years old.
2. BMI between 18.5 kg/m² and 30 kg/m².
3. Subjects who are overtly healthy as determined by the investigator.
4. Able to speak and read in French.
5. Willing and able to collect their faecal samples themselves.
6. Having access to adequate space to store the investigational.
7. Regular bowel movements.
8. Willing to consume the study products twice per day for 28 consecutive days.
9. Willing not to consume any fermented dairy products during the entire study, other than the study products.
10. Willing not to consume any probiotic, prebiotic or synbiotic supplements during the entire study.
11. Willing to limit alcohol consumption during the study.
12. Willing not to smoke tobacco during the study.
13. Willing not to use any soft or hard drug during the study.
14. Signed written informed consent by the participant.
15. Female subjects must either be postmenopausal for at least 12 months or have undergone specific surgical procedures resulting in sterility or they are using one of the medically approved contraceptive methods.
16. Subject is covered by French health insurance.
17. Subject agrees to be registered in the national database of subjects participating in clinical research.
18. Subject is willing and able to complete the electronic Patient Reported Outcomes using their own digital device having access to internet.

Exclusion Criteria:

1. Any ongoing metabolic disease, hypertension, inflammatory disease, thyroid disease, allergic conditions requiring chronic systemic medication, psychiatric disorder, gastrointestinal disorder, chronic pain, or neurological disorder diagnosed by a physician.
2. Known with allergy or intolerance to any ingredients or allergens.
3. Pregnancy or breast-feeding at the screening visit or plan for pregnancy during the study.
4. Any antecedents of digestive surgery, or plan for such surgery during the study.
5. Any dental surgery within the last 4 weeks before the screening visit, or plan for dental surgery during the study.
6. Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks before the screening visit, or who plans to have one during the study.
7. Unable (or unwilling) to adhere to protocol requirements.
8. Subject with a special diet at the screening visit, or plan for such diet during the study.
9. 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.
10. 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.
11. Use ≤ 8 weeks before the screening visit or plan of use during the study of systemic medication that can affect the gastrointestinal function or plan of use during the study (if needed, incidental use of ≤ 4 tablets of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin per 2-week period is allowed.
12. Excessive alcohol consumption during the past 6 months before the screening visit.
13. Active smoker, or quit active smoking less than 5 years ago before the screening visit. Not regularly smoking is allowed.
14. Drug abuse based on investigator's judgement.
15. Participation in another study with investigational or marketed products potentially affecting the gut microbiota ≤ 4 weeks before the screening visit or plan for participation in any other intervention study during the study.
16. Living in the same home as others already participating in the study and to concomitantly receive some study products.
17. Subject under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
18. Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \& Innovation Center.
19. Subject's total compensation for participation in clinical studies within the past 12 months, including the compensation expected from the Mellifera study, would exceed the annual ceiling of €6,000.

Where it's running

  • Cen
    Dijon, France
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.