Stools and Life Habits Collection in Heathy Volunteers/Subjects - to Provide Material for in Vitro Model Development

NCT04301973 | Completed

• 1 other identifier: NU387
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Stool collection; Human samples collection; Healthy subject; Life habits questionnaires; Diet questionnaires

Outcome Measures

Primary Outcomes (3)

• Characterized the consistency of stool collected from 4-days diet diary questionnaire after 14 days of dietary restrictions

  After 14 days

• Characterized the consistency of stool collected from the Intestinal Gas Questionnaire (IGQ) after 14 days of dietary restrictions

  After 14 days

• Characterized the consistency of stool collected from the Bristol Stool Scale (BSS) after 14 days of dietary restrictions

  After 14 days

Secondary Outcomes (3)

• Description of the dietary habits from the Food Frequency Questionnaire at Baseline

  Baseline

• Description of the life style habits from the International Physical Activity Questionnaire Short Form, at Baseline and after 14 days of dietary restrictions

  Baseline and after 14 days

• Description of the smoking habits from the tobacco questionnaire at Baseline

  Baseline

Study Arms (1)

Healthy people

OTHER

Other: Stool collection

Interventions

Stool collection OTHER

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.

Healthy people

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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:
• HT3 receptor antagonists,
• Anticholinergic agents (tricyclic antidepressants, antiparkinsonian drugs, antipsychotics, antispasmodics, antihistamines),
• Anticonvulsants,
• Antihypertensives (calcium channel blockers, diuretics, centrally acting, antiarrhythmics, beta-adrenoreceptor antagonist),
• 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);
• E14. Any significant systemic disease such as, but not limited to:

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Biofortis

Saint-Herblain, 44800, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 10, 2020
• Study Start: September 2, 2020
• Primary Completion: December 18, 2020
• Study Completion: January 20, 2021
• Last Updated: March 2, 2021

Record last verified: 2020-12

Locations

FR (1)