protocolSection identificationModule nctId: NCT06376695, orgStudyIdInfo id: RADX-P-2407, briefTitle: Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Radicle Science, class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes, conditionsModule conditions: Abdominal Pain, conditions: GI Disorders, conditions: Digestion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: Radicle GI Health Placebo Control Form 1, interventions name: Radicle GI Health Active Study Product 1.1 Usage, outcomesModule primaryOutcomes measure: Change in GI (Gastrointestinal) Health (1), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (2), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (3), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (4), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (5), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (6), secondaryOutcomes measure: Change in feelings of anxiety, secondaryOutcomes measure: Change in GI-related Quality of Life (QOL), secondaryOutcomes measure: Change in mood (emotional distress-depression), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (1), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (2), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (3), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (4), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (5), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (6), secondaryOutcomes measure: Minimal clinically important difference (MCID) in feelings of anxiety, secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI-related QOL, secondaryOutcomes measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression), otherOutcomes measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radicle Science, Inc, city: Del Mar, state: California, zip: 92014, country: United States, geoPoint lat: 32.95949, lon: -117.26531, hasResults: False