protocolSection identificationModule nctId: NCT06317441, orgStudyIdInfo id: NIMCSF137, briefTitle: The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Nimble Science Ltd., class: INDUSTRY, collaborators name: Lallemand Health Solutions, descriptionModule briefSummary: In this study, the goal is to evaluate whether a probiotic formula may reduce symptoms of bloating and abdominal distension in a population suffering from Small Intestinal Bacterial Overgrowth (SIBO) in comparison to a placebo. In addition to the incidence of SIBO, changes to other gastrointestinal symptoms will be assessed. Lastly, the associations between the SIBO status and microbiome from the small and large intestines will be explored using the SIMBA capsule., conditionsModule conditions: Small Intestinal Bacterial Overgrowth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Change in bloating/distension severity, secondaryOutcomes measure: Median bloating-free days, secondaryOutcomes measure: Change in median bloating/distension severity, secondaryOutcomes measure: Change in abdominal discomfort/pain, secondaryOutcomes measure: Changes in gastrointestinal symptoms, secondaryOutcomes measure: Changes in stool frequency and consistency, secondaryOutcomes measure: Changes in the quality of life, secondaryOutcomes measure: Changes in reflux incidence and severity, secondaryOutcomes measure: Changes in the severity of IBS symptoms, secondaryOutcomes measure: Recovery rate of the probiotic strain, secondaryOutcomes measure: Microbiome changes within small intestine, fecal and saliva samples, secondaryOutcomes measure: Investigation how the microbiome and SIBO associate with each other though bacterial population analyses., secondaryOutcomes measure: Change in SIBO positivity rate, otherOutcomes measure: Exploratory metabolomic analysis, otherOutcomes measure: Exploratory: Quantifying B. subtilis cell proportions, otherOutcomes measure: Safety outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nimble Science, city: Calgary, state: Alberta, zip: T2L 1Y8, country: Canada, contacts name: Gwen Duytschaever, role: CONTACT, phone: 4037032436, email: Gwen@nimblesci.com, contacts name: Christopher N Andrews, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Nimble Science, city: Calgary, state: Alberta, zip: T2L 1Y8, country: Canada, contacts name: Marsha Burnes, role: CONTACT, phone: 4037032436, email: Marsha@nimblesci.com, contacts name: Christopher N Andrews, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False