Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Pa… (NCT06308146) | Clinical Trial Compass
CompletedNot Applicable
Effect of Bacillus Subtilis ATCC 122264 Supplementation on Gas Symptoms and Quality of Life in Participants With Functional Bloating
Canada100 participantsStarted 2022-04-21
Plain-language summary
A randomized, double blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of Bacillus subtillis in providing relief and improving quality of life in participants suffering from functional abdominal bloating/distension when administered for a period of 8 weeks.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Healthy adult participants who are 18 to 65 years of age (inclusive).
* Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
* In good general health (no active or uncontrolled diseases or conditions).
* Participants with Functional Abdominal Bloating/Distension, defined by ROME IV criteria as below: Must meet both of the following diagnostic criteria fulfilled for the last three months with symptom onset ≥ 6 months prior to diagnosis: a) Recurrent bloating and/or distension occurring on average at least 1 day/week, and abdominal bloating and/or distension predominates over other symptoms (bloating-related mild pain may be present as well as minor bowel movement abnormalities). b) There are insufficient criteria for a diagnosis of irritable bowel syndrome, functional constipation, functional diarrhea, or post-prandial distress syndrome.
* Individuals of childbearing potential must have negative urine pregnancy result at baseline and agree to practice acceptable form of birth control for a certain period prior to the first dose of study product and throughout the study duration.
* Individuals with the potential to get others pregnant must agree to use condom or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
* Be willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, …
What they're measuring
1
Effect on intestinal gas symptoms and quality of life