Flatulence, Bloating
Conditions
Brief summary
Efficacy of probiotics on excessive gas accumulation
Interventions
DIETARY_SUPPLEMENTProbiotic supplement
Probiotic supplement
DIETARY_SUPPLEMENTPlacebo supplement
Placebo supplement
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath hydrogen | 4 hours | The level of breath hydrogen is measured after a challenge with lactulose |
Countries
Sweden
Outcome results
None listed