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 (BREEZE)

Danone

Status

Completed

Conditions

Excessive Intestinal Gas Production

Treatments

Other: Milk product fermented by lactic bacteria or not fermented

Study type

Interventional

Funder types

Industry

Identifiers

NCT03015441

NU378

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)