FlatulenceNCT03134469
Efficacy of Probiotics on Excessive Gas Accumulation
A study testing Probiotic supplement in people with Flatulence and Bloating, run by Probi AB at 2 sites in Sweden.
Trial summary
Efficacy of probiotics on excessive gas accumulation Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Flatulence, Bloating
- What is being tested?
- Probiotic supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesSweden
- Study dates
- 18 Apr 2017to 19 Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 18-50 years, at the time of signing the informed consent.
- Willing and able to give written informed consent for participating in the study
- Willing to comply with all study procedures
Who cannot join
- Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
- Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
- Known gluten intolerance, lactose intolerance, milk protein allergy
- Vegetarian diet
- Intake of antibiotics within four weeks prior to the start of the study
- Hypersensitivity to any of the ingredients in the investigational product (IP)
Show all 9Show fewer
- Regular intake of probiotics within four weeks prior to the start of the study
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
2 sites in 1 country.
About this study
Efficacy of probiotics on excessive gas accumulation
- Conditions
- Flatulence, Bloating
- Being tested
- Probiotic supplement, Placebo supplement
- Medical subject headings
- Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementDietary supplement
Probiotic supplement
Placebo supplementDietary supplement
Placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Intake of a probiotic capsule once daily Receives: Dietary Supplement: Probiotic supplement |
| Placebo | Placebo comparator | Intake of a placebo capsule once daily Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath hydrogen
The level of breath hydrogen is measured after a challenge with lactulose
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start18 Apr 2017
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatulenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134469
- Sponsor's protocol ID
- ProGastro 17
- Status last verified
- Sep 2018
- First submitted
- 26 Apr 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics on Excessive Gas Accumulation
- ClinicalTrials.gov ID
- NCT03134469
- Acronym / sponsor ID
- ProGastro 17
- Conditions
- Flatulence, Bloating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 1 May 2017 (actual)
- 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.
Efficacy of probiotics on excessive gas accumulation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotic supplementIntake of a probiotic capsule once daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementIntake of a placebo capsule once daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults 18-50 years, at the time of signing the informed consent.
- Willing and able to give written informed consent for participating in the study
- Willing to comply with all study procedures
Key exclusion criteria (9 listed)
- Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
- Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
- Known gluten intolerance, lactose intolerance, milk protein allergy
- Vegetarian diet
- Intake of antibiotics within four weeks prior to the start of the study
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 |
|---|---|---|
| Probiotic supplementProbiotic supplement | Dietary supplement | Probiotics |
| Placebo supplementPlacebo supplement | Dietary supplement | Placebo |
Primary outcome
Breath hydrogen
Time frame: 4 hours
The level of breath hydrogen is measured after a challenge with lactulose
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 25 Sep 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplement in people with Flatulence and Bloating, run by Probi AB at 2 sites in Sweden.
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 9 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. Some participants in this study may receive a placebo. 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?
Breath hydrogen (time frame: 4 hours). 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 25 Sep 2018.