Impact of Fermented Dairy and Bifidobacteria on Gut Health

A Randomised, Controlled, Double-blind, Three Parallel Groups, Multi-centre Study to Assess the Bifidobacterium Diversity After 28-days Consumption of Fermented Dairy Products With Three Bifidobacterium Strains With or Without Galacto-oligosaccharides Compared to Yoghurt in 45 to 60-year-old Healthy Subjects

This study tests if eating a fermented dairy product with certain good bacteria can improve gut health in healthy adults aged 45 to 60.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 45 Years to 60 Years
• Sex: All
• Sponsor: Danone Global Research & Innovation Center (Industry-sponsored)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT06799364 on ClinicalTrials.gov

What this trial studies

This study investigates how the consumption of specific Bifidobacterium strains, with and without the addition of galacto-oligosaccharides (GOS), affects the gut microbiome in healthy adults aged 45 to 60. Participants will consume either a fermented dairy product or a control product for 28 days, while their gut health will be monitored through faecal sample analysis. The goal is to clarify the survival of these beneficial bacteria in the gastrointestinal tract and their overall impact on gut health.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 45 to 60 with a BMI between 18.5 and 30.

Not a fit: Patients with existing gastrointestinal disorders or those taking probiotics or prebiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of gut microbiota management and improve digestive health through dietary interventions.

How similar studies have performed: Previous studies have shown promising results regarding the benefits of Bifidobacteria and prebiotics on gut health, suggesting this approach has potential.

Eligibility 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. 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 to consume any fermented dairy products during the entire study (other than the study products) as well as any probiotic, prebiotic or synbiotic supplements during the entire study.
   * Complete the electronic Patient Reported Outcomes (ePRO) using their own digital device having access to internet.
5. Willing to limit alcohol consumption and not to smoke or consume any soft or hard drug during the study.
6. Having access to adequate space to store the investigational products in their own fridge at home.
7. Having regular bowel movements.
8. Signed written informed consent by the participant.
9. 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.
10. Subject is covered by French health insurance.
11. Subject agrees to be registered in the national database of subjects participating in clinical research.

Exclusion Criteria:

1. 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.
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 the study.
4. 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.

7. Unable (or unwilling) to adhere to protocol requirements (based on investigator's judgement).

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

13. Drug abuse based on investigator's judgement.

14. Living in the same home as others already participating in the study and to concomitantly receive some study products.

15. Subject under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.

16. Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \& Innovation Center.

Where this trial is running

Paris and 1 other locations

• Biofortis — Paris, France (Recruiting)
• Biofortis — Saint-Herblain, France (Recruiting)

Study contacts

• Study coordinator: Danone Global Research & Innovation Center

Conditions A03 - Digestive System; B03 - Bacteria; Gut microbiota; Fibre; Yoghurt; Bifidobacteria diversity; Galacto-oligosaccharides