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

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

Study Overview

• Status: Completed
• Conditions: Microbiota Perturbation by an Environmental Challenge
• Intervention / Treatment: Dietary supplement: Fibers and probiotics

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1000
    • Société des produits Nestlé/Metabolic Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Experimental: Nutrition intervention; Ingestion of fibers and probiotics daily for 22 days	Dietary supplement: Fibers and probiotics; A blend of fibers and seven probiotics

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased intestinal microbiota diversity	Measured by the Shannon diversity index	Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Increased microbiota gene richness	Measured by gene counts from metagenome sequencing of the fecal microbiota	Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Gut comfort	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)	Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Sami Damak, Société des Produits Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2020
• Primary Completion (Actual): September 25, 2020
• Study Completion (Actual): September 25, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19.17.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No