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)

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

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.

Study Overview

• Status: Completed
• Conditions: Excessive Intestinal Gas Production
• Intervention / Treatment: Other: Milk product fermented by lactic bacteria or not fermented

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • CRS Clinical Research Services Mannheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1: Fermented milk product containing probiotics	Other: Milk product fermented by lactic bacteria or not fermented; 2 pots of 125g consumed daily during 28 days
Other: Arm 2: Milk-based non-fermented dairy product	Other: Milk product fermented by lactic bacteria or not fermented; 2 pots of 125g consumed daily during 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Danone Research
• Investigators: Study Chair: Boris Le NEVE, PhD, Danone Research, Palaiseau, France

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): May 4, 2017
• Study Completion (Actual): June 21, 2017

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Probiotics; Healthy subjects; Gut microbiota; Breath test; Methane; Intestinal gas production; Dihydrogen
• Other Study ID Numbers: NU378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No