protocolSection identificationModule nctId: NCT06313346, orgStudyIdInfo id: 2023.200, briefTitle: Effect of a Probiotic on Microbiota Associated With the Immune System and Inflammation., acronym: FLORABIOTIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Clinica Universidad de Navarra, Universidad de Navarra, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention.The main questions to answer are:1. To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake.2. To evaluate changes in salivary cortisol after ingestion of the probiotic.3. To compile the number and intensity of catarrhal episodes suffered by the participants along the study.For this purpose, a randomized, double blind parallel study has been designed.Target sample size is 60 subjects.Participants will be allocated in two groups for 6 weeks:* Experimental group (n=30): daily consumption of one probiotic capsule.* Placebo group (n=30): daily consumption of one placebo capsule., conditionsModule conditions: Probiotic, conditions: Microbiota, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised, double blinded, parallel intervention, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: The products (experimental and placebo), will be produced by an external producer, who will save the codes. None of the researchers involved in the study development or analyses will know the association until the end of the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Fecal microbiota, secondaryOutcomes measure: Salivary cortisol, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Body fat percentage, secondaryOutcomes measure: Body muscle mass, secondaryOutcomes measure: Body lean mass, secondaryOutcomes measure: Body water mass, secondaryOutcomes measure: Body bone mass, secondaryOutcomes measure: The incidence of catarrhal episodes, secondaryOutcomes measure: The gravity of catarrhal episodes, secondaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Adherence to capsule consumption, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Nutrition Research, status: RECRUITING, city: Pamplona, state: Navarre, zip: 31008, country: Spain, contacts name: Fermin Milagro, PhD, role: CONTACT, phone: 948425600, phoneExt: 806553, email: fmilagro@unav.es, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False