NCT03015441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

January 2, 2017

Last Update Submit

August 21, 2017

Conditions

Excessive Intestinal Gas Production

Keywords

Healthy subjectsProbioticsBreath testDihydrogenMethaneIntestinal gas productionGut microbiota

Outcome Measures

Primary Outcomes (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

    Baseline and after 28 days

Secondary Outcomes (3)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Arm 1: Fermented milk product containing probiotics

OTHER
Other: Milk product fermented by lactic bacteria or not fermented

Arm 2: Milk-based non-fermented dairy product

OTHER
Other: Milk product fermented by lactic bacteria or not fermented

Interventions

Milk product fermented by lactic bacteria or not fermentedOTHER

2 pots of 125g consumed daily during 28 days

Arm 1: Fermented milk product containing probioticsArm 2: Milk-based non-fermented dairy product

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Study Officials

  • Boris Le NEVE, PhD

    Danone Research, Palaiseau, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 10, 2017

Study Start

February 2, 2017

Primary Completion

May 4, 2017

Study Completion

June 21, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)