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

Not Applicable

Completed

• Conditions: Microbiota Perturbation by an Environmental Challenge
• Interventions: Dietary Supplement: Fibers and probiotics

• Registration Number: NCT04424329
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-02
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Primary Completion: 2020-09-25
• Study Completion: 2020-09-25
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nutrition intervention	Fibers and probiotics	Ingestion of fibers and probiotics daily for 22 days

Primary Outcome Measures

Name	Time	Method
Minimizing microbiota composition change	Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)	Shotgum metagenomics

Secondary Outcome Measures

Name	Time	Method
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
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
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)

Trial Locations

Locations (1)

Société des produits Nestlé/Metabolic Unit; 🇨🇭 Lausanne, Switzerland