Excessive Intestinal Gas ProductionBREEZENCT03015441
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 study testing Milk product fermented by lactic bacteria or not fermented in people with Excessive Intestinal Gas Production, run by Danone Global Research & Innovation Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Intestinal Gas Production
- What is being tested?
- Milk product fermented by lactic bacteria or not fermented
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2017to 21 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical Research Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
About this study
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
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.
- Conditions
- Excessive Intestinal Gas Production
- Being tested
- Milk product fermented by lactic bacteria or not fermented
- Keywords
- Healthy subjects, Probiotics, Breath test, Dihydrogen, Methane, Intestinal gas production, Gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk product fermented by lactic bacteria or not fermentedOther
2 pots of 125g consumed daily during 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Fermented milk product containing probiotics | Other | Not described Receives: Other: Milk product fermented by lactic bacteria or not fermented |
| Arm 2: Milk-based non-fermented dairy product | Other | Not described Receives: Other: Milk product fermented by lactic bacteria or not fermented |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, after 14 days and after 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start2 Feb 2017
- Primary completion4 May 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Intestinal Gas ProductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Le NEVE, PhD, Study chair, Danone Research, Palaiseau, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015441
- Sponsor's protocol ID
- NU378
- Acronym
- BREEZE
- Status last verified
- Aug 2017
- First submitted
- 2 Jan 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03015441
- Acronym / sponsor ID
- BREEZE / NU378
- Conditions
- Excessive Intestinal Gas Production
- Keywords
- Healthy subjects, Probiotics, Breath test, Dihydrogen, Methane, Intestinal gas production, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk product fermented by lactic bacteria or not fermented2 pots of 125g consumed daily during 28 days | Other | Arm 1: Fermented milk product containing probiotics, Arm 2: Milk-based non-fermented dairy product |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Le NEVE, PhD study chair
Danone Research, Palaiseau, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk product fermented by lactic bacteria or not fermented in people with Excessive Intestinal Gas Production, run by Danone Global Research & Innovation Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and after 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.