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 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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2017-06-21

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.

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Detailed Description

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Conditions

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Excessive Intestinal Gas Production

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1: Fermented milk product containing probiotics

Group Type OTHER

Milk product fermented by lactic bacteria or not fermented

Intervention Type OTHER

2 pots of 125g consumed daily during 28 days

Arm 2: Milk-based non-fermented dairy product

Group Type OTHER

Milk product fermented by lactic bacteria or not fermented

Intervention Type OTHER

2 pots of 125g consumed daily during 28 days

Interventions

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Milk product fermented by lactic bacteria or not fermented

2 pots of 125g consumed daily during 28 days

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes