A03 - Digestive SystemThreeB (TB)NCT06799364
Fermented Dairy Product and Bifidobacterium Diversity (ThreeBees)
A study testing 28-days consumption of Product A in 45 to 60-year-old healthy subjects. and 28-days consumption of Product B in 45 to 60-year-old healthy subjects. in people with A03 - Digestive System and B03 - Bacteria, run by Danone Global Research & Innovation Center at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- A03 - Digestive System, B03 - Bacteria
- What is being tested?
- 28-days consumption of Product A in 45 to 60-year-old healthy subjects. and 28-days consumption of Product B in 45 to 60-year-old healthy subjects.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 3 sitesFrance
- Study dates
- 21 Feb 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: 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.
- Conditions
- A03 - Digestive System, B03 - Bacteria
- Being 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.
- Keywords
- Gut microbiota, Fibre, Yoghurt, Bifidobacteria diversity, Galacto-oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral administration of experimental product A | Experimental | Test product A: fermented dairy product containing Bifidobacterium strains Receives: 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) Receives: 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 Receives: Other: 28-days consumption of Control product in 45 to 60-year-old healthy subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species.
Measured: 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.
Measured: After 28 days of study product consumption
The change from baseline after 28-days product consumption of Bifidobacterium diversity indices.
Measured: After 28 days of study product consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start21 Feb 2025
- Primary completion22 Dec 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A03 - Digestive SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799364
- Sponsor's protocol ID
- 23REX0060156
- Acronym
- ThreeB (TB)
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06799364
- Acronym / sponsor ID
- ThreeB (TB) / 23REX0060156
- Conditions
- A03 - Digestive System, B03 - Bacteria
- Keywords
- Gut microbiota, Fibre, Yoghurt, Bifidobacteria diversity, Galacto-oligosaccharides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral administration of experimental product A | Experimental | Other: 28-days consumption of Product A in 45 to 60-year-old healthy subjects.Test product A: fermented dairy product containing Bifidobacterium strains |
| Oral administration of experimental product B | Experimental | Other: 28-days consumption of Product B in 45 to 60-year-old healthy subjects.Test product B: product A with galacto-oligosaccharides (GOS) |
| Oral administration of Control product | Placebo comparator | Other: 28-days consumption of Control product in 45 to 60-year-old healthy subjects.Control product: commercially available yoghurt |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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:
- Willing to limit alcohol consumption and not to smoke or consume any soft or hard drug during the study.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Oral administration of experimental product A |
| 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 | Oral administration of experimental product B |
| 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. | Other | Oral administration of Control product |
Primary outcome
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
2 secondary outcomes
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.
Time frame: After 28 days of study product consumption
The change from baseline after 28-days product consumption of Bifidobacterium diversity indices.
Time frame: After 28 days of study product consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 28-days consumption of Product A in 45 to 60-year-old healthy subjects. and 28-days consumption of Product B in 45 to 60-year-old healthy subjects. in people with A03 - Digestive System and B03 - Bacteria, run by Danone Global Research & Innovation Center at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.