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

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

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

Conditions
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Microbiota Perturbation by an Environmental Challenge

Intervention / Treatment
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* Dietary Supplement: Fibers and probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition intervention<br>Ingestion of fibers and probiotics daily for 22 days | Dietary Supplement: Fibers and probiotics<br>* A blend of fibers and seven probiotics<br>|
| No Intervention: No intervention<br>No intervention | |

What is the study measuring?
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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) |