A03 - Digestive SystemStoColMNCT06988514
Stool Collection for Model
A study testing Standardized stool collection from healthy volunteers in people with A03 - Digestive System and 03 - Bacteria, run by Danone Global Research & Innovation Center at 1 site in France.
Trial summary
Purpose of this study is to collect stool samples from healthy volunteers 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, 03 - Bacteria
- What is being tested?
- Standardized stool collection from healthy volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2025to 23 Dec 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
- Male and female participants aged between 18-60 years.
- 18.5 ≤ BMI < 30 kg/m2.
- Overtly healthy as determined by the Investigator.
- Regular bowel movements and a mean stool consistency of 3-5 in Bristol Stool Form Scale (BSFS) during the past week.
- Able to:
- Collect their stool samples and delivered at site.
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- Speak and read in French.
- Comply with the study protocol and to commit to the instructions and restrictions.
- Refrain from any fermented dairy products throughout the study conduct.
- Refrain from prebiotic, probiotic or synbiotic supplements during the study.
- Maintain the dose of other consumed supplements during the study.
- Limit alcohol consumption to ≤ 2 units (i.e., standard glasses) of alcohol per day with a maximum of 10 units per week during the study.
- Not change substantially their smoking habits during the study.
- Written informed consent Form (ICF) signed by the participant.
- No substantial changes in diet and/or physical activity and/or lifestyle habits, defined as start or stop new foods and/or supplements and/or sports and/or daily habits (i.e., travel, sleeping habits) during the study.
- Have a personal electronic device compatible and connectable to internet to access the web based MyFood24 site when required.
- Covered by social security or similar system.
- Agree to be registered in the National biomedical research file for volunteers.
Who cannot join
- Any ongoing metabolic disease, inflammatory disease, hepato-gastrointestinal dis-ease or complications, psychiatric or neurological disorder or other diagnosed by a physician.
- Any invasive diagnostic and/or therapeutic procedure related to digestion within the past 4 weeks or plan for a digestive surgery during the study, including dental sur-gery, (i.e., from the onset of the wash-out period to the last data collection).
- General anesthesia during the past 4 weeks or planned during the course of the study.
- For women in childbearing potential, pregnancy or breastfeeding or plan for preg-nancy during the study.
- Use of medication that affects the gastrointestinal (GI) function or use of stomach medication within the past 4 weeks or plan to use of any of these during the study.
- Non-incidental use of > 4 paracetamol tablets (500 mg), nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin ≤ 2 weeks before the screening visit (V1) or plan of use during the study (if needed, incidental use of ≤ 4 tablets of paracetamol, NSAIDs or aspirin per 2-week period (i.e. ≤ 4 tablets during the refrain period, ≤ 4 tab-lets during the study).
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- Antibiotic, antifungal, antiviral or antiparasitic medication within the past 6 months.
- Use of any soft drugs, cannabidiol (CBD), plants medicines and/or hard drugs during the study.
- Participant of another study with investigational or marketed products which could the gut microbiota within the past 4 weeks or plan to participate in such a study dur-ing the study.
- Participant under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
- Employees and/or children/family members or relatives of employees of Danone or the participating sites such as medical, pharmacy, dental and nursing students, sub-ordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention.
- Having received, during the last 12 months, indemnities for participation into clinical study exceeding the annual threshold of 6000€ (including participation to this study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Exploratory, Interventional Clinical Study for Stool Samples Collection in Healthy Participants to Use and Further Advance Some Danone Research Applications
Purpose of this study is to collect stool samples from healthy volunteers
- Conditions
- A03 - Digestive System, 03 - Bacteria
- Being tested
- Standardized stool collection from healthy volunteers
- Keywords
- Stool, Microbiota, In vitro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized stool collection from healthy volunteersOther
The only interventions are clinical examination, dietary restrictions and samples collection (stool, and urine for the pregnancy tests (when applicable).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer collecting stool samples | Experimental | Healthy volunteer collecting and bringing their stool samples to the investigational site. Receives: Other: Standardized stool collection from healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect enough acceptable stool samples
Measured: After 14 days of refrain period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start19 Jun 2025
- Primary completion20 Nov 2025
- Study completion23 Dec 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
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT06988514
- Sponsor's protocol ID
- 24REX0077603
- Acronym
- StoColM
- Status last verified
- Jan 2026
- First submitted
- 16 May 2025
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Exploratory, Interventional Clinical Study for Stool Samples Collection in Healthy Participants to Use and Further Advance Some Danone Research Applications
- ClinicalTrials.gov ID
- NCT06988514
- Acronym / sponsor ID
- StoColM / 24REX0077603
- Conditions
- A03 - Digestive System, 03 - Bacteria
- Keywords
- Stool, Microbiota, In vitro
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 25 May 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.
Purpose of this study is to collect stool samples from healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer collecting stool samples | Experimental | Other: Standardized stool collection from healthy volunteersHealthy volunteer collecting and bringing their stool samples to the investigational site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Male and female participants aged between 18-60 years.
- 18.5 ≤ BMI < 30 kg/m2.
- Overtly healthy as determined by the Investigator.
- Regular bowel movements and a mean stool consistency of 3-5 in Bristol Stool Form Scale (BSFS) during the past week.
- Able to:
Key exclusion criteria (12 listed)
- Any ongoing metabolic disease, inflammatory disease, hepato-gastrointestinal dis-ease or complications, psychiatric or neurological disorder or other diagnosed by a physician.
- Any invasive diagnostic and/or therapeutic procedure related to digestion within the past 4 weeks or plan for a digestive surgery during the study, including dental sur-gery, (i.e., from the onset of the wash-out period to the last data collection).
- General anesthesia during the past 4 weeks or planned during the course of the study.
- For women in childbearing potential, pregnancy or breastfeeding or plan for preg-nancy during the study.
- Use of medication that affects the gastrointestinal (GI) function or use of stomach medication within the past 4 weeks or plan to use of any of these during the study.
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 |
|---|---|---|
| Standardized stool collection from healthy volunteersThe only interventions are clinical examination, dietary restrictions and samples collection (stool, and urine for the pregnancy tests (when applicable). | Other | Healthy volunteer collecting stool samples |
Primary outcome
Collect enough acceptable stool samples
Time frame: After 14 days of refrain period
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 6 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized stool collection from healthy volunteers in people with A03 - Digestive System and 03 - 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 18 inclusion and 12 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 6 Jan 2026. 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?
Collect enough acceptable stool samples (time frame: After 14 days of refrain period). 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 6 Jan 2026.