Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excessive Intestinal Gas Production
Keywords: Healthy subjects
Probiotics
Breath test
Dihydrogen
Methane
Intestinal gas production
Gut microbiota
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Baseline and after 28 days
Secondary outcomes:
measure: 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
timeFrame: Baseline and after 14 days
measure: 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
timeFrame: Baseline, after 14 days and after 28 days
measure: 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
timeFrame: Baseline, after 14 days and after 28 days
Other outcomes:
measure: 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
timeFrame: Baseline, after 28 days
measure: Adverse event
timeFrame: AE and SAE assessment through study completion and up to 14 days after the last study visit
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Research Services Mannheim GmbH
state: Baden-Württemberg
Study officials:
affiliation: Danone Research, Palaiseau, France
name: Boris Le NEVE, PhD
role: STUDY_CHAIR
References: