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
Not Applicable
Completed
- Conditions
- Excessive Intestinal Gas Production
- Interventions
- Other: Milk product fermented by lactic bacteria or not fermented
- Registration Number
- NCT03015441
- Lead Sponsor
- Danone Research
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Fermented milk product containing probiotics Milk product fermented by lactic bacteria or not fermented - Arm 2: Milk-based non-fermented dairy product Milk product fermented by lactic bacteria or not fermented -
- Primary Outcome Measures
Name Time Method 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 Baseline and after 28 days
- Secondary Outcome Measures
Name Time Method 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 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 Baseline, after 14 days and after 28 days 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 Baseline and after 14 days
Trial Locations
- Locations (1)
CRS Clinical Research Services Mannheim GmbH
🇩🇪Mannheim, Baden-Württemberg, Germany