protocolSection identificationModule nctId: NCT06283784, orgStudyIdInfo id: YOVIS Capsules, briefTitle: Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-05, primaryCompletionDateStruct date: 2021-11-02, completionDateStruct date: 2022-05-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Biofarma, class: INDUSTRY, collaborators name: Hippocrates Research, descriptionModule briefSummary: This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days), conditionsModule conditions: Diarrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double blind, randomized, placebo-controlled study., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. Product test and placebo capsules will be indistinguishable.Investigational food supplement products will be packed in an individual way for each subject included in the investigation., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Yovis Capsules, interventions name: Placebo, outcomesModule primaryOutcomes measure: Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy, secondaryOutcomes measure: Severity and duration of AAD, secondaryOutcomes measure: Severity and duration of AAD, secondaryOutcomes measure: Evaluation of duration and severity of gastrointestinal symptoms, secondaryOutcomes measure: Evaluation of duration and severity of gastrointestinal symptoms, secondaryOutcomes measure: Evaluation of duration and severity of gastrointestinal symptoms, secondaryOutcomes measure: Impact of bowel habits on QoL, secondaryOutcomes measure: Effects of YOVIS, versus placebo, at each visit on the overall health status, secondaryOutcomes measure: Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo, secondaryOutcomes measure: Global Patient's self-reported acceptance at the end of study, secondaryOutcomes measure: Global acceptability (investigator) at the end of study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Practitioner Ambulatory, city: Sanremo, state: Italy/Imperia, zip: 18038, country: Italy, geoPoint lat: 43.81725, lon: 7.7772, hasResults: False