Microbiota Perturbation by an Environmental Challenge
Conditions
Brief summary
The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress
Interventions
DIETARY_SUPPLEMENTFibers and probiotics
A blend of fibers and seven probiotics
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Informed consent signed 2. Adult men and women aged 18 to 45 years 3. Healthy based on the medical screening visit and medical questionnaire 4. BMI in the range of 18.5 to 29.9 kg/m2.
Exclusion criteria
1. Known food allergy and intolerance 2. Currently participating in another clinical trial or research project 3. Fewer than 5 spontaneous bowel movements per week on average 4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily 5. Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment 6. Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment 7. Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents 8. Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy) 9. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. 10. Artificially sweetened beverage intake higher than 1000 ml/ per day 11. Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating. 12. Subject having a hierarchical or family link with the research team members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimizing microbiota composition change | Daily from Day -4 to day + 7 (Day 0 is the start of the challenge) | Shotgum metagenomics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increased intestinal microbiota diversity | Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge) | Measured by the Shannon diversity index |
| Increased microbiota gene richness | Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge) | Measured by gene counts from metagenome sequencing of the fecal microbiota |
| Gut comfort | Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge) | Assessed each Gastrointestinal Symptoms (VOMITING, NAUSEA, AUDIBLE BOWEL SOUNDS, FLATULENCE, ABDOMINAL CRAMPS, BLOATING ) with a scale (from 0 to 10, 10 being the worst outcome) |
Countries
Switzerland
Outcome results
None listed