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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-22

Study Completion Date

2016-12-23

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

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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.

Conditions

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Functional Gastrointestinal Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1=Functional Gastro-Intestinal Disorder (FGID)

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)

Group Type EXPERIMENTAL

Fermented milk product with probiotics (FMPP)

Intervention Type OTHER

2 pots of 125g FMPP / day

2=Non-FGID

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)

Group Type EXPERIMENTAL

Fermented milk product with probiotics (FMPP)

Intervention Type OTHER

2 pots of 125g FMPP / day

Interventions

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Fermented milk product with probiotics (FMPP)

2 pots of 125g FMPP / day

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes