Efficacy of Probiotics on Excessive Gas Accumulation

NCT03134469 — Not applicable, Completed, 64 participants, Probi AB

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RegistryNCT03134469
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: quadruple, prevention
Enrollment64 (Actual)
SponsorProbi AB (Industry)
ConditionsFlatulence, Bloating
InterventionsProbiotic supplement, Placebo supplement (Dietary supplement)
Datesstart 2017-04-18, primary completion 2017-10-19, completion 2017-10-19, first posted 2017-05-01, last updated 2018-09-25
Locations2 sites in Sweden

Related Papers Related Patents Related Grants Related Experts
All trials for Flatulence All trials for Bloating All trials of Probiotic supplement All trials of Placebo supplement

-Summary

Efficacy of probiotics on excessive gas accumulation

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+Arms and interventions

ArmTypeInterventionsDescription
ProbioticsExperimentalDietary Supplement: Probiotic supplementIntake of a probiotic capsule once daily
PlaceboPlacebo comparatorDietary Supplement: Placebo supplementIntake of a placebo capsule once daily
  • Probiotic supplement (Dietary supplement): Probiotic supplement
  • Placebo supplement (Dietary supplement): Placebo supplement

+Outcome measures

Primary outcomes

  • Breath hydrogen [4 hours]: The level of breath hydrogen is measured after a challenge with lactulose

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

+Locations (2)

FacilityCityCountryStatus
Lund UniversityLundSweden
CTC Clinical ConsultantsUppsalaSweden