Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms

Study Overview
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Brief Summary
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To select among different dietary and clinical conditions the most appropriate to assess the impact of a fermented milk product on gas-related symptoms

Detailed Description
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To select among different dietary (mild or high flatulogenic diet) and clinical conditions (FGID or non-FGID population) as well as different measured parameters (self-completed questionnaires assessing gas related symptoms, digestive well-being and bowel functions, gas volume distribution in the colon by MRI, volume and composition of gas collected per anus and frequency of gas evacuations per anus), the most appropriate to assess the impact of a fermented milk product on gas-related symptoms.

Official Title
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Exploratory Study Aiming at Assessing the Impact of Specific and Controlled Diets Combined With a Fermented Milk Product on Gas-related Symptoms and Associated Measurements in FGID and Non-FGID Subjects

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Other: Fermented milk product with probiotics (FMPP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1=FGID group: Subject with body mass index (BMI) between 18.5 and 30.0 kg/m2 (bounds excluded); Subject with a functional gastrointestinal disorder according to ROME III criteria; Subject complaining of excessive intestinal gas evacuation (i.e. flatulence); Subject willing to follow strict dietary instructions; Subject who normally consumes dairy products; 2=Non-FGID group: Subject with body mass index (BMI) between 18.5 and 30.0 kg/m2 (bounds excluded); Subject with no functional gastrointestinal disorder according to ROME III criteria; Subject with no gastrointestinal disorders according to investigator's medical assessment; Subject willing to follow strict dietary instructions; Subject who normally consumes dairy products Exclusion Criteria: 1=FGID group: Subject with any disease/disorder which can interfere with the gas collection; Subject with any antecedents of digestive surgery; Subject with any intake of antibiotics in the previous 2 months; Subject with any current use of any medication with potential central nervous system effects (except for chronic treatment with anxiolytics and antidepressants started at least 3 months before inclusion in the study); Subject taking drugs that might modify gastrointestinal function (except for chronic treatment with laxatives, started at least 3 months before inclusion in the study) ; 2=Non-FGID group: Subject with any disease/disorder which can interfere with the gas collection; Subject with any antecedents of digestive surgery; Subject with any intake of antibiotics in the previous 2 months; Subject with any current use of any medication with potential central nervous system effects; Subject taking drugs that might modify gastrointestinal function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1=Functional Gastro-Intestinal Disorder (FGID)<br>1=FGID study group: 40 evaluable FGID subjects with a functional gastrointestinal disorder (FGID) complaining of excessive gas evacuation per anus (i.e excessive flatulence), aged from 18 to 75 years that will consume a 3-day specific and controlled mild flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product) | Other: Fermented milk product with probiotics (FMPP)<br>* 2 pots of 125g FMPP / day<br>|
| Experimental: 2=Non-FGID<br>2=Non-FGID study group: 60 evaluable non-FGID subjects aged from 18 to 75 years that will consume a 3-day specific controlled high flatulogenic diet twice at 25 days of interval (combined or not with a fermented milk product) | Other: Fermented milk product with probiotics (FMPP)<br>* 2 pots of 125g FMPP / day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of gas evacuations per anus | Change in number of gas evacuations per anus: number of events will be recorded daily using a gas event counter, during a 3-day baseline period and during two 3-day periods of controlled diet before and after a 28-day study product consumption period. | during a 3-day baseline period and during two 3-day periods of controlled diet before and after a 28-day study product consumption period | 
| Change in intestinal gas volume | Change in intestinal gas volume: gas volume evacuated per anus will be continuously collected and measured every 15 minutes during 4 hours by a specific device, at the time of a standardized breakfast and following a 3-day period of controlled diet before and after a 28- day study product consumption period. | following a 3-day period of controlled diet before and after a 28- day study product consumption period | 
| Change in intestinal gas composition | Change in intestinal gas composition: amount of different types of gas (H2, CO2, CH4, O2, N2, H2S, mercaptans) from the 4-hours intestinal gas collection sample will be determined by gas chromatography following a 3- day period of controlled diet before and after a 28-day study product consumption period. | following a 3- day period of controlled diet before and after a 28-day study product consumption period | 
| Change in colonic gas volume/segmental distribution | Change in colonic gas volume/segmental distribution: total gas volume and distribution in the different regions of the colon (ascending, transverse, descending, sigmoid/rectum) will be determined using intestinal MRI following a 3-day period of controlled diet before and after a 28-day study product consumption period. | following a 3-day period of controlled diet before and after a 28-day study product consumption period | 
| Gas related symptoms (self-completed questionnaire) |  | 3 days | 
| Digestive well-being (self-completed questionnaire) |  | 3 days | 
| Composition of gut microbiota (molecular biology methods) |  | 5 days | 
| Bowel function (self-completed questionnaire; bristol stool scale) |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gas, flatulence, probiotics, fermented milk, diet, functional gastrointestinal disorders