| Registry | NCT03134469 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: quadruple, prevention |
| Enrollment | 64 (Actual) |
| Sponsor | Probi AB (Industry) |
| Conditions | Flatulence, Bloating |
| Interventions | Probiotic supplement, Placebo supplement (Dietary supplement) |
| Dates | start 2017-04-18, primary completion 2017-10-19, completion 2017-10-19, first posted 2017-05-01, last updated 2018-09-25 |
| Locations | 2 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
Efficacy of probiotics on excessive gas accumulation
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotic supplement | Intake of a probiotic capsule once daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplement | Intake of a placebo capsule once daily |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Lund University | Lund | Sweden | |
| CTC Clinical Consultants | Uppsala | Sweden |