Completed

NCT Number: NCT03015441

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

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.

Completed

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Key information

Conditions

Excessive Intestinal Gas Production

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRS Clinical Research Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Milk product fermented by lactic bacteria or not fermented

Other

2 pots of 125g consumed daily during 28 days

Primary outcomes

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

Time frame: Baseline and after 28 days

Secondary outcomes

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

Time frame: 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

Time frame: 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

Time frame: Baseline, after 14 days and after 28 days

Other outcomes

Comparison between groups of the change in composition and activity of gut microbiota from stool samples collected before and after 28 days of investigational product consumption

Time frame: Baseline, after 28 days
Adverse event

Time frame: AE and SAE assessment through study completion and up to 14 days after the last study visit

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

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

Acronym: BREEZE

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 10, 2017
Registry last updated: Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.