NCT06799364

Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Danone Global Research & Innovation Center · Industry
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2025-02-21
• Primary completion: 2025-12-22
• Completion: 2026-04-01
• First posted: 2025-01-29
• Last updated: 2026-01-14

Locations

3 sites across 1 country: France