Status:
COMPLETED
Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Microbiota Perturbation by an Environmental Challenge
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress
Eligibility Criteria
Inclusion
- Informed consent signed
- Adult men and women aged 18 to 45 years
- Healthy based on the medical screening visit and medical questionnaire
- BMI in the range of 18.5 to 29.9 kg/m2.
Exclusion
- Known food allergy and intolerance
- Currently participating in another clinical trial or research project
- Fewer than 5 spontaneous bowel movements per week on average
- Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
- Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
- Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
- Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
- Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
- 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.
- Artificially sweetened beverage intake higher than 1000 ml/ per day
- Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
- Subject having a hierarchical or family link with the research team members.
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04424329
Start Date
June 2 2020
End Date
September 25 2020
Last Update
November 13 2020
Active Locations (1)
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1
Société des produits Nestlé/Metabolic Unit
Lausanne, Switzerland, 1000