Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees)

NCT06799364 | Completed

• 1 other identifier: 23REX0060156
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

A03 - Digestive System; B03 - Bacteria

Keywords

Gut microbiota; Fibre; Yoghurt; Bifidobacteria diversity; Galacto-oligosaccharides

Outcome Measures

Primary Outcomes (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.

  After 28 days of study product consumption

Secondary Outcomes (2)

• 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

Study Arms (3)

Oral administration of experimental product A

EXPERIMENTAL

Test product A: fermented dairy product containing Bifidobacterium strains

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

Oral administration of experimental product B

EXPERIMENTAL

Test product B: product A with galacto-oligosaccharides (GOS)

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

Oral administration of Control product

PLACEBO COMPARATOR

Control product: commercially available yoghurt

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

Interventions

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

48 healthy volunteers will consume Product A twice per day during 28 consecutive days.

Oral administration of experimental product A

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

48 healthy volunteers will consume Product B twice per day during 28 consecutive days.

Oral administration of experimental product B

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

48 healthy volunteers will consume Control product twice per day during 28 consecutive days.

Oral administration of Control product

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• 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.
• Signed written informed consent by the participant.
• 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.
• Subject is covered by French health insurance.
• Subject agrees to be registered in the national database of subjects participating in clinical research.

You may not qualify if:

• 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.
• 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).
• 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.
• Drug abuse based on investigator's judgement.
• Living in the same home as others already participating in the study and to concomitantly receive some study products.
• Subject under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
• Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \& Innovation Center.

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (3)

CEN

Dijon, France

Location

Biofortis

Paris, France

Location

Biofortis

Saint-Herblain, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: February 21, 2025
• Primary Completion: December 22, 2025
• Study Completion: April 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)