An interventional study of Milk product fermented by lactic bacteria or not fermented in Excessive Intestinal Gas Production, sponsored by Danone Global Research & Innovation Center. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Danone Global Research & Innovation Center · Not applicable, Interventional, and Treatment
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.
Danone Global Research & Innovation Center is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Milk product fermented by lactic bacteria or not fermented
Other: Milk product fermented by lactic bacteria or not fermented
2 pots of 125g consumed daily during 28 days
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
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Danone Global Research & Innovation Center