Effect of a Specific Blend of Fibers and Probiotics on the Microbiome

Société des Produits Nestlé (SPN)1 site in 1 country20 target enrollmentJune 2, 2020

Overview

The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress

Registry

clinicaltrials.gov

Start Date

June 2, 2020

End Date

September 25, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

•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

Minimizing microbiota composition change

Time Frame: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)

Shotgum metagenomics

Increased intestinal microbiota diversity(Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge))
Increased microbiota gene richness(Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge))
Gut comfort(Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge))