Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Fermented milk product containing probiotics | Other |
| |
| Arm 2: Milk-based non-fermented dairy product | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk product fermented by lactic bacteria or not fermented | Other | 2 pots of 125g consumed daily during 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, after 28 days | |
| Adverse event | AE and SAE assessment through study completion and up to 14 days after the last study visit |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boris Le NEVE, PhD | Danone Research, Palaiseau, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | Baden-Wurttemberg | 68167 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |