Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of a 28-day fermented milk product consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in healthy subjects high H2 producers.

Official Title
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Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers A Randomized, Controlled, Double-blind, Parallel Arms, Adaptive Study

Conditions
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Excessive Intestinal Gas Production

Intervention / Treatment
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* Other: Milk product fermented by lactic bacteria or not fermented


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with body mass index (BMI) between 18.0 and 30.0 kg/m2 (bounds excluded) Subjects having a high dihydrogen (H2) production as defined by a fasting exhaled level of H2 in breath at 10 parts per million (ppm) or more. Women of childbearing potential must be using a medically approved method of contraception OR women must be postmenopausal for at least 12 months prior to study entry Exclusion Criteria: Subject with functional gastrointestinal disorder according to ROME III criteria (Functional Bowel Disorders/FBD module, Functional Dyspepsia/FD module, Irritable Bowel Syndrome/IBS module) Subject with gastrointestinal disorders according to investigator's medical assessment Subject taking drugs that might modify gastrointestinal function Subject with severe disease as assessed by the investigator (ex: cancer, severe heart disease, kidney disease, neurological disease or psychiatric disease, immunodeficiency disorder)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1: Fermented milk product containing probiotics<br> | Other: Milk product fermented by lactic bacteria or not fermented<br>* 2 pots of 125g consumed daily during 28 days<br>|
| Other: Arm 2: Milk-based non-fermented dairy product<br> | Other: Milk product fermented by lactic bacteria or not fermented<br>* 2 pots of 125g consumed daily during 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between groups of the change from baseline (Day0) of breath H2 production elicited by a lactulose challenge test after 28 days of investigational product consumption |  | Baseline and after 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between groups of the change from baseline (Day0) of breath H2 production elicited by a lactulose challenge test after 14 days of investigational product consumption |  | Baseline and after 14 days | 
| Comparison between groups of the change from baseline (Day0) of breath CH4 production elicited by a lactulose challenge test after 14 days and 28 days of investigational product consumption |  | Baseline, after 14 days and after 28 days | 
| Comparison between groups of the change from baseline (Day0) in the fasting breath H2 and CH4 values after 14 days and 28 days of investigational product consumption |  | Baseline, after 14 days and after 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Healthy subjects, Breath test, Dihydrogen, Methane, Intestinal gas production, Gut microbiota