Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees) (ThreeB (TB))

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

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.

Study Overview

• Status: Completed
• Conditions: A03 - Digestive System; B03 - Bacteria
• Intervention / Treatment: Other: 28-days consumption of Product A in 45 to 60-year-old healthy subjects.; Other: 28-days consumption of Product B in 45 to 60-year-old healthy subjects.; Other: 28-days consumption of Control product in 45 to 60-year-old healthy subjects.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • CEN
  • Paris, France
    • Biofortis
  • Saint-Herblain, France
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.
5. Unable (or unwilling) to adhere to protocol requirements (based on investigator's judgement).
6. Subject with a special diet at the screening visit, or plan for such diet during the study.
7. 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.
8. 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.
9. 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).
10. 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.
11. Drug abuse based on investigator's judgement.
12. Living in the same home as others already participating in the study and to concomitantly receive some study products.
13. Subject under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
14. Employees, family members or other relatives of employees of the participating centre or of Danone Global Research & Innovation Center.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral administration of experimental product A; Test product A: fermented dairy product containing Bifidobacterium strains	Other: 28-days consumption of Product A in 45 to 60-year-old healthy subjects.; 48 healthy volunteers will consume Product A twice per day during 28 consecutive days.
Experimental: Oral administration of experimental product B; Test product B: product A with galacto-oligosaccharides (GOS)	Other: 28-days consumption of Product B in 45 to 60-year-old healthy subjects.; 48 healthy volunteers will consume Product B twice per day during 28 consecutive days.
Placebo Comparator: Oral administration of Control product; Control product: commercially available yoghurt	Other: 28-days consumption of Control product in 45 to 60-year-old healthy subjects.; 48 healthy volunteers will consume Control product twice per day during 28 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species.	After 28 days of study product consumption

Secondary Outcome Measures

Outcome Measure	Time Frame
The changes from baseline after 28-days product consumption in detection and quantification of viable bacteria (i.e. with intact cell membrane) for the Bifidobacterium strains.	After 28 days of study product consumption
The change from baseline after 28-days product consumption of Bifidobacterium diversity indices.	After 28 days of study product consumption

Collaborators and Investigators

• Sponsor: Danone Global Research & Innovation Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Actual): December 22, 2025
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gut microbiota; Galacto-oligosaccharides; Fibre; Yoghurt; Bifidobacteria diversity
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 23REX0060156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No