Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015441
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Excessive Intestinal Gas Production Other: Milk product fermented by lactic bacteria or not fermented Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : June 21, 2017

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Other Outcome Measures:
  1. 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 ]
  2. Adverse event [ Time Frame: AE and SAE assessment through study completion and up to 14 days after the last study visit ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015441


Locations
Layout table for location information
Germany
CRS Clinical Research Services Mannheim GmbH
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Danone Research
Investigators
Layout table for investigator information
Study Chair: Boris Le NEVE, PhD Danone Research, Palaiseau, France
Layout table for additonal information
Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT03015441    
Other Study ID Numbers: NU378
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danone Research:
Healthy subjects
Probiotics
Breath test
Dihydrogen
Methane
Intestinal gas production
Gut microbiota