Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees)

Last updated: February 26, 2025
Sponsor: Danone Global Research & Innovation Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

28-days consumption of Product B in 45 to 60-year-old healthy subjects.

28-days consumption of Control product in 45 to 60-year-old healthy subjects.

28-days consumption of Product A in 45 to 60-year-old healthy subjects.

Clinical Study ID

NCT06799364
23REX0060156
  • Ages 45-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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. Willing and/or able to:

  • Speak and read in French,

  • Collect, store and transport their faecal samples themselves,

  • Consume the study products twice per day for 28 consecutive days and not toconsume any fermented dairy products during the entire study (other than thestudy products) as well as any probiotic, prebiotic or synbiotic supplementsduring the entire study.

  • Complete the electronic Patient Reported Outcomes (ePRO) using their owndigital device having access to internet.

  1. Willing to limit alcohol consumption and not to smoke or consume any soft or harddrug during the study.

  2. Having access to adequate space to store the investigational products in their ownfridge at home.

  3. Having regular bowel movements.

  4. Signed written informed consent by the participant.

  5. Female subjects must either be postmenopausal for at least 12 months or haveundergone specific surgical procedures resulting in sterility or they are using oneof the medically approved contraceptive methods.

  6. Subject is covered by French health insurance.

  7. Subject agrees to be registered in the national database of subjects participatingin clinical research.

Exclusion

Exclusion Criteria:

  1. Any ongoing metabolic disease, hypertension, inflammatory disease, allergicconditions requiring chronic systemic medication, psychiatric disorder,gastrointestinal disorder, chronic pain, or neurological disorder diagnosed by aphysician.

  2. Known allergy or intolerance to any ingredients or potential allergens.

  3. Pregnancy or breast-feeding at the screening visit or plan for pregnancy during thestudy.

  4. Any antecedents or plan for digestive or dental surgery, general anaesthesia or anyparticipation in another study with investigational or marketed products potentiallyaffecting the gut microbiota.

  5. Unable (or unwilling) to adhere to protocol requirements (based on investigator'sjudgement).

  6. Subject with a special diet at the screening visit, or plan for such diet during thestudy.

  7. Major changes in subject's dietary habits ≤ 4 weeks before the screening visit orplan for such major changes during the study including change in vitamin or mineralsupplements use, but except for dietary restrictions related to the study.

  8. Enhanced diet together with intense physical activity ≤ 4 weeks before the screeningvisit, plan for such a diet and training during the study, or plan for major changesin physical activity during the study.

  9. Use ≤ 8 weeks before the screening visit or plan of use during the study of systemicmedication that can affect the gastrointestinal function or plan of use during thestudy (if needed, incidental use of ≤ 4 tablets of paracetamol, non-steroidalanti-inflammatory drugs (NSAIDs) or aspirin per 2-week period is allowed).

  10. Subject with excessive alcohol consumption, active smoker or quit active smokingless than 5 years ago before the screening visit. Not regularly smoking is allowed.

  11. Drug abuse based on investigator's judgement.

  12. Living in the same home as others already participating in the study and toconcomitantly receive some study products.

  13. Subject under guardianship, curatorship, person under judicial protection, familyempowerment or future protection mandate.

  14. Employees, family members or other relatives of employees of the participatingcentre or of Danone Global Research & Innovation Center.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: 28-days consumption of Product B in 45 to 60-year-old healthy subjects.
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Biofortis

    Paris,
    France

    Active - Recruiting

  • Biofortis

    Saint-Herblain,
    France

    Active - Recruiting

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