A03 - Digestive SystemSurvi PBNCT06768229
Survival Plant-Based
A study testing Consumption of a freeze-dried strains-mix. in people with A03 - Digestive System and B03 - Bacteria, run by Danone Global Research & Innovation Center at 1 site in France.
Trial summary
The aim of this study is to explore the potential of a mix of 4 freeze-dried bifidobacteria strains from Danone collection to survive in human gastro-intestinal (GI) tract of healthy volunteers after 14 days of consumption. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- A03 - Digestive System, B03 - Bacteria
- What is being tested?
- Consumption of a freeze-dried strains-mix.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2025to 13 May 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years.
- Body Mass Index (BMI) between 18.5-30.0 kg/m2.
- Willing to consume twice per day for at least 14 days the study product diluted in 1 glass of still water.
- Availability to comply with the protocol and timetable.
- Having regular bowel movements (on ≥6 days/week).
- French speaking and reading.
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- Subject willing to adhere to the specific instructions and restrictions for the entire duration of the study.
- Signed (written) informed consent from participant.
- Subject is covered by a French health insurance.
- Agree to be registered in the national database of subjects participating in clinical research.
- Have a smartphone/computer compatible and connectable to internet, and subject is willing and able to complete the electronic Patient Reported Outcomes (ePRO) using it.
- Women of childbearing potential must be using a medically approved method of contraception, or be with a surgically sterile partner or be with a partner of the same sex.
Who cannot join
- Subject who used within 8 weeks prior to the screening visit or are planning to use during the conduct of this study one of the listed prohibited medications that might modify gastrointestinal function. Incidental use (1 or 2 pills/tablets) of non-steroidal anti-inflammatory drugs and aspirin is allowed, if required.
- Subject following special diet at the screening visit (V1), or plan for such diet during the study.
- Subject having any previous abdominal surgery, or plan for such surgery during the study.
- Subject who underwent a general anesthesia in the preceding 4 weeks before the screening visit (V1).
- Subject with any metabolic disease, hypertension, any inflammatory disease, any psychiatric disorder, or any gastrointestinal disorder, all these medical conditions should have been diagnosed by a physician.
- Subject with any known food allergy or intolerance to any of the study product components or to any potential traces.
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- Active smoker with 7 or more cigarettes per week.
- Subject doing high intensity physical activity in combination with following an enhanced diet within 1 month before screening or planned during the participation of the study.
- Subject who underwent dental surgery within the last 4 weeks before the screening visit (V1) or plan dental surgery during the course of the study.
- Pregnant woman or woman planning to become pregnant during the study or breastfeeding woman.
- Participation in another study with investigational or marketed products potentially affecting the gut microbiota ≤ 4 weeks before the screening visit (V1) or plan for participation in any other intervention study during the study.
- Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center or the participating site.
- Subject under guardianship or curatorship.
- Excessive alcohol consumption during the past 6 months before the screening visit (V1).
- Drug abuse, based on investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm, Open-label, Single-center Exploratory Study to Assess the Survival of Bifidobacteria's Strains in Human Gastro-intestinal Tract of Healthy Volunteers After 14 Days of Consumption of a Mix of 4 Freeze-dried Strains.
The aim of this study is to explore the potential of a mix of 4 freeze-dried bifidobacteria strains from Danone collection to survive in human gastro-intestinal (GI) tract of healthy volunteers after 14 days of consumption.
To this aim, one study group of 20 healthy volunteers will consume freeze-dried strains- mix twice per day diluted in 1 glass of still water during 14 consecutive days.
- Conditions
- A03 - Digestive System, B03 - Bacteria
- Being tested
- Consumption of a freeze-dried strains-mix.
- Keywords
- Strains, Survival, Bifidobacterium, Intestinal microbiota
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of a freeze-dried strains-mix.Other
One study group of 20 healthy volunteers will consume freeze-dried strains-mix twice per day diluted in 1 glass of still water during 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Assess the survival of Bifidobacteria's strains in the GI tract after consumption of strains mix | Experimental | One study group of 20 healthy volunteers will consume freeze-dried strains- mix twice per day diluted in 1 glass of still water during 14 consecutive days. Receives: Other: Consumption of a freeze-dried strains-mix. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 14 days of study product consumption in healthy adults.
Measured: After 14 days of study product consumption
Comparison of the quantity of total and alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces before and after 14 days of study product consumption in healthy adults.
Measured: After 14 days of study product consumption
Presence of alive bacteria of the provided specific strains of each of the Bifidobacterium strains in feces after 1 week of follow-up in healthy adults.
Measured: After 1 week of follow-up
Comparison of the quantity of total and alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 1 week of follow-up in healthy adults.
Measured: After 1 week of follow-up
Secondary outcomes (1)
Dietary intakes collected by dietary recall (using MyFood24 software) of the previous day of the faecal samples collection for V2, V3 and V4 of healthy adult subjects.
Measured: After 1 week of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start9 Jan 2025
- Primary completion14 Mar 2025
- Study completion13 May 2025
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label, single-center, exploratory study
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT06768229
- Sponsor's protocol ID
- 23REX0060157
- Acronym
- Survi PB
- Status last verified
- Jun 2025
- First submitted
- 19 Dec 2024
- Last updated
- 22 Jun 2025
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Open-label, Single-center Exploratory Study to Assess the Survival of Bifidobacteria's Strains in Human Gastro-intestinal Tract of Healthy Volunteers After 14 Days of Consumption of a Mix of 4 Freeze-dried Strains.
- ClinicalTrials.gov ID
- NCT06768229
- Acronym / sponsor ID
- Survi PB / 23REX0060157
- Conditions
- A03 - Digestive System, B03 - Bacteria
- Keywords
- Strains, Survival, Bifidobacterium, Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 10 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.
The aim of this study is to explore the potential of a mix of 4 freeze-dried bifidobacteria strains from Danone collection to survive in human gastro-intestinal (GI) tract of healthy volunteers after 14 days of consumption.
To this aim, one study group of 20 healthy volunteers will consume freeze-dried strains- mix twice per day diluted in 1 glass of still water during 14 consecutive days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label, single-center, exploratory study
| Arm | Type | Receives |
|---|---|---|
| Assess the survival of Bifidobacteria's strains in the GI tract after consumption of strains mix | Experimental | Other: Consumption of a freeze-dried strains-mix.One study group of 20 healthy volunteers will consume freeze-dried strains- mix twice per day diluted in 1 glass of still water during 14 consecutive days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 18-60 years.
- Body Mass Index (BMI) between 18.5-30.0 kg/m2.
- Willing to consume twice per day for at least 14 days the study product diluted in 1 glass of still water.
- Availability to comply with the protocol and timetable.
- Having regular bowel movements (on ≥6 days/week).
Key exclusion criteria (15 listed)
- Subject who used within 8 weeks prior to the screening visit or are planning to use during the conduct of this study one of the listed prohibited medications that might modify gastrointestinal function. Incidental use (1 or 2 pills/tablets) of non-steroidal anti-inflammatory drugs and aspirin is allowed, if required.
- Subject following special diet at the screening visit (V1), or plan for such diet during the study.
- Subject having any previous abdominal surgery, or plan for such surgery during the study.
- Subject who underwent a general anesthesia in the preceding 4 weeks before the screening visit (V1).
- Subject with any metabolic disease, hypertension, any inflammatory disease, any psychiatric disorder, or any gastrointestinal disorder, all these medical conditions should have been diagnosed by a physician.
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 |
|---|---|---|
| Consumption of a freeze-dried strains-mix.One study group of 20 healthy volunteers will consume freeze-dried strains-mix twice per day diluted in 1 glass of still water during 14 consecutive days. | Other | Assess the survival of Bifidobacteria's strains in the GI tract after consumption of strains mix |
Primary outcome
Presence of alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 14 days of study product consumption in healthy adults.
Time frame: After 14 days of study product consumption
Comparison of the quantity of total and alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces before and after 14 days of study product consumption in healthy adults.
Time frame: After 14 days of study product consumption
Presence of alive bacteria of the provided specific strains of each of the Bifidobacterium strains in feces after 1 week of follow-up in healthy adults.
Time frame: After 1 week of follow-up
Comparison of the quantity of total and alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 1 week of follow-up in healthy adults.
Time frame: After 1 week of follow-up
1 secondary outcome
Dietary intakes collected by dietary recall (using MyFood24 software) of the previous day of the faecal samples collection for V2, V3 and V4 of healthy adult subjects.
Time frame: After 1 week of follow-up
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 22 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of a freeze-dried strains-mix. in people with A03 - Digestive System and B03 - Bacteria, run by Danone Global Research & Innovation Center at 1 site 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 12 inclusion and 15 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 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Presence of alive bacteria of each of the provided specific strains of Bifidobacterium strains in feces after 14 days of study product consumption in healthy adults. (time frame: After 14 days of study product consumption). The study lists 4 primary outcomes in all. 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 22 Jun 2025.