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NCT06799364: 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
NA trial testing 28-days consumption of Product A in 45 to 60-year-old healthy subjects. in A03 - Digestive System in 182 participants. Completed in 15 April 2026.
22 December 2025
Quick facts
| Lead sponsor | Danone Global Research & Innovation Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 182 |
| Start date | 21 February 2025 |
| Primary completion | 22 December 2025 |
| Estimated completion | 15 April 2026 |
| Sites | 3 locations across France |
Drugs / interventions tested
- 28-days consumption of Product A in 45 to 60-year-old healthy subjects.
- 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.
Conditions studied
- A03 - Digestive System — all drugs for A03 - Digestive System →
- B03 - Bacteria — all drugs for B03 - Bacteria →
Sponsor
Danone Global Research & Innovation Center — full company profile →
Who can join
Adults 45 to 60, any sex, with A03 - Digestive System or B03 - Bacteria. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species.
Time frame: After 28 days of study product consumption
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06799364
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Danone Global Research & Innovation Center trials
Trials by the same sponsor.
- NCT06836752 — Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects · NA · terminated
- NCT06988514 — Stool Collection for Model · NA · completed
- NCT06768229 — Survival Plant-Based · NA · completed
- NCT05416151 — Effect of B.Lactis Consumption on Gastro-Intestinal (GI) Symptoms in Healthy Women Reporting Minor GI Symptoms · NA · completed
- NCT04780763 — Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Sub · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06799364 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Danone Global Research & Innovation Center
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06799364.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing