Healthy SubjectsPEPSIINNCT04301973
Stools and Life Habits Collection in Heathy Volunteers/Subjects - to Provide Material for in Vitro Model Development
A study testing Stool collection in people with Healthy Subjects, run by Danone Global Research & Innovation Center at 1 site in France.
Trial summary
The purpose of this clinical study is to collect well characterized stools from healthy adult subjects, with completed life habits and alimentary questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Stool collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to 20 Jan 2021
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- I1. Age between 18 and 69 years (limits included), I2. Body Mass Index (BMI) between 20 and 25 kg/m² (lower limit excluded and upper limit included), I3. Having regular Spontaneous Bowel Movements at the interview (a minimal of 7 SBMs per week is considered as regular);
- I4. Ability to follow study procedures including at least:
- Stool collection, sampling, handling and storage throughout the duration of the study,
- Questionnaires and daily diet diary completion throughout the duration of the study,
- No substantial change in physical activity, diet regimen during the study period, I5. No prior medical consultation (primary or follow-up) for constipation or diarrhea, linked or not to infectious diseases, within the last 6 months; I6. Subject who accepts not to consume listed specific products including: yoghurts, fermented dairy products with probiotics and/or prebiotics, over-the-counter (OTC) medication containing probiotics and/or prebiotics, OTC medication such as herbal plants, psyllium, hormonal derivatives (e.g. melatonin, Dehydroepiandrosterone (DHEA) ...), food and nutritional supplements (e.g. vitamins and / or minerals such as Iron, Calcium and Magnesium) (called "prohibited products");
- I7. For female subject: If woman of child bearing age, she must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively:
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- Oral birth control pills at least 1 full monthly cycle prior to study;
- Intra-uterine device (IUD);
- Double barrier methods (such as condoms and spermicide); OR woman without contraception must be postmenopausal for at least 12 months prior to study entry or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or bilateral tubal ligation).
- I8. Good general health in the opinion of the investigator: no clinically significant and relevant abnormalities revealed by medical history or physical examination, I9. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form, I10. Affiliated with a social security scheme, I11. Agree to be registered in the National biomedical research file for volunteers.
Who cannot join
- E1. For female subject: pregnant woman or woman planning to become pregnant during the study or breast-feeding woman; E2. Ongoing - diagnosed gastrointestinal acute or chronic disease or complication (e.g; IBS, Crohn's disease, hemorrhoids, …);
- E3. Previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function:
- 5-HT3 receptor antagonists,
- Anticholinergic agents (tricyclic antidepressants, antiparkinsonian drugs, antipsychotics, antispasmodics, antihistamines),
- Anticonvulsants,
- Antihypertensives (calcium channel blockers, diuretics, centrally acting, antiarrhythmics, beta-adrenoreceptor antagonist),
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- Bile acid sequestrants,
- Cation-containing agents (aluminum, bismuth, lithium),
- Chemotherapy agents (vinca alkaloids, alkylating agents),
- Laxatives or antidiarrheal drugs,
- Anti-Gastro- oesophageal reflux disease (GORD) medication
- Pain treatment/analgesics (opiates) except paracetamol or aspirin if occasional intake,
- Non-Steroidal Anti-Inflammatory Drugs (NSAID, including cortisone) if regular use
- Serotonin-Specific Reuptake Inhibitor (SSRI);
- Change of contraceptive method hormone replacement therapy for female subjects E4. Current or previous antibiotic, antifungal and antiparasitic treatment within 6 months; E5. Subject that have had any invasive diagnostic or therapeutic procedure(s) (except drawing blood), including dental surgery, with or without general or local anesthesia within the last 4 weeks or planned during the course of the study; E6. Subject with gastric or duodenal ulcer; E7. Shiftworker, subject going on holiday, subject planning to have its lifestyle habits modified (international travel, aircraft staff …) during study period; E8. Alcohol (consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women), drugs or medication abuse; E9. Known gluten intolerance, lactose intolerance and allergy to milk proteins; E10. Subject who stopped smoking, including the electronic cigarette, within 3 last months or intends to give up smoking during the study; E11. Subject who is following a special diet (e.g. slimming or vegetarian/vegan diets, medicated diet prescribed by a dietician or general practitioner such as a low cholesterol diet, low salt diet, low FODMAP, specific high-fiber diet, paleolithic or ketogenic diets…); E12. Subject enrolled in another clinical study in the last 30 days or in an exclusion period following participation in another clinical study; E13. Subject with severe life-threatening illness;
- E14. Any significant systemic disease such as, but not limited to:
- Subjects who are currently suffering from an eating disorder such as anorexia or bulimia;
- Mechanical obstruction (colon cancer, external compression, strictures, postsurgical abnormalities, known megacolon, anal fissure);
- Metabolic conditions (diabetes mellitus, hypothyroidism, hypercalcemia, hypokalemia, hypomagnesia, uremia, heavy metal poisoning);
- Myopathies (amyloidosis, scleroderma);
- Neuropathies (Parkinson's disease, spinal cord injury or tumor, cerebrovascular disease, multiple sclerosis);
- History of asthma, hay fever, or other allergies;
- Other conditions (depression, degenerative joint disease, autonomic neuropathy, cognitive impairment, immobility, cardiac and cardiovascular diseases).
- E15. Vulnerable subject defined as individual whose willingness to volunteer in the clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (Examples are members of a group with a hierarchical structure linked to the Investigator or to the Sponsor, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention); E16. Having received, during the last 12 months, indemnities for clinical study higher or equal to 4500 Euros; E17. Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject; E18. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; E19. Presenting a psychological or linguistic incapability to sign the informed consent; E20. Impossible to contact in case of emergency.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical study is to collect well characterized stools from healthy adult subjects, with completed life habits and alimentary questionnaires.
- Conditions
- Healthy Subjects
- Being tested
- Stool collection
- Keywords
- Stool collection, Human samples collection, Healthy subject, Life habits questionnaires, Diet questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collectionOther
There is no intervention with a product in this study. The healthy subject has just to come 2 times in the clinical trial unit for clinical exam including urinary pregnancy test, fill life habits and diet questionnaires, and provide one stool sample for the 2nd visit, after 2 weeks of alimentary restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy people | Other | Not described Receives: Other: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterized the consistency of stool collected from 4-days diet diary questionnaire after 14 days of dietary restrictions
Measured: After 14 days
Characterized the consistency of stool collected from the Intestinal Gas Questionnaire (IGQ) after 14 days of dietary restrictions
Measured: After 14 days
Characterized the consistency of stool collected from the Bristol Stool Scale (BSS) after 14 days of dietary restrictions
Measured: After 14 days
Secondary outcomes (3)
Description of the dietary habits from the Food Frequency Questionnaire at Baseline
Measured: Baseline
Description of the life style habits from the International Physical Activity Questionnaire Short Form, at Baseline and after 14 days of dietary restrictions
Measured: Baseline and after 14 days
Description of the smoking habits from the tobacco questionnaire at Baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start2 Sep 2020
- Primary completion18 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 18 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
- NCT04301973
- Sponsor's protocol ID
- NU387
- Acronym
- PEPSIIN
- Status last verified
- Dec 2020
- First submitted
- 3 Mar 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stools and Life Habits Collection in Heathy Volunteers/Subjects - to Provide Material for in Vitro Model Development
- ClinicalTrials.gov ID
- NCT04301973
- Acronym / sponsor ID
- PEPSIIN / NU387
- Conditions
- Healthy Subjects
- Keywords
- Stool collection, Human samples collection, Healthy subject, Life habits questionnaires, Diet questionnaires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 10 Mar 2020 (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 purpose of this clinical study is to collect well characterized stools from healthy adult subjects, with completed life habits and alimentary questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy people | Other | Other: Stool collection |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- I1. Age between 18 and 69 years (limits included), I2. Body Mass Index (BMI) between 20 and 25 kg/m² (lower limit excluded and upper limit included), I3. Having regular Spontaneous Bowel Movements at the interview (a minimal of 7 SBMs per week is considered as regular);
- Stool collection, sampling, handling and storage throughout the duration of the study,
- Questionnaires and daily diet diary completion throughout the duration of the study,
- No substantial change in physical activity, diet regimen during the study period, I5. No prior medical consultation (primary or follow-up) for constipation or diarrhea, linked or not to infectious diseases, within the last 6 months; I6. Subject who accepts not to consume listed specific products including: yoghurts, fermented dairy products with probiotics and/or prebiotics, over-the-counter (OTC) medication containing probiotics and/or prebiotics, OTC medication such as herbal plants, psyllium, hormonal derivatives (e.g. melatonin, Dehydroepiandrosterone (DHEA) ...), food and nutritional supplements (e.g. vitamins and / or minerals such as Iron, Calcium and Magnesium) (called "prohibited products");
- I7. For female subject: If woman of child bearing age, she must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively:
Key exclusion criteria (24 listed)
- E1. For female subject: pregnant woman or woman planning to become pregnant during the study or breast-feeding woman; E2. Ongoing - diagnosed gastrointestinal acute or chronic disease or complication (e.g; IBS, Crohn's disease, hemorrhoids, …);
- E3. Previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function:
- 5-HT3 receptor antagonists,
- Anticholinergic agents (tricyclic antidepressants, antiparkinsonian drugs, antipsychotics, antispasmodics, antihistamines),
- Anticonvulsants,
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 |
|---|---|---|
| Stool collectionThere is no intervention with a product in this study. The healthy subject has just to come 2 times in the clinical trial unit for clinical exam including urinary pregnancy test, fill life habits and diet questionnaires, and provide one stool sample for the 2nd visit, after 2 weeks of alimentary restrictions. | Other | Healthy people |
Primary outcome
Characterized the consistency of stool collected from 4-days diet diary questionnaire after 14 days of dietary restrictions
Time frame: After 14 days
Characterized the consistency of stool collected from the Intestinal Gas Questionnaire (IGQ) after 14 days of dietary restrictions
Time frame: After 14 days
Characterized the consistency of stool collected from the Bristol Stool Scale (BSS) after 14 days of dietary restrictions
Time frame: After 14 days
3 secondary outcomes
Description of the dietary habits from the Food Frequency Questionnaire at Baseline
Time frame: Baseline
Description of the life style habits from the International Physical Activity Questionnaire Short Form, at Baseline and after 14 days of dietary restrictions
Time frame: Baseline and after 14 days
Description of the smoking habits from the tobacco questionnaire at Baseline
Time frame: Baseline
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 2 Mar 2021.
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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 Stool collection in people with Healthy Subjects, 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 10 inclusion and 24 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 2 Mar 2021. 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?
Characterized the consistency of stool collected from 4-days diet diary questionnaire after 14 days of dietary restrictions (time frame: After 14 days). The study lists 3 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 2 Mar 2021.