Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-02 @ 3:19 PM
Study NCT ID:
NCT07130058
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radicle GI HealthTM RCA: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gas and Bloating', 'timeFrame': '7 weeks', 'description': 'Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-60; where the higher scores correspond to worse gas and bloating)'}], 'secondaryOutcomes': [{'measure': 'Change in Gi-related Quality of Life (QOL)', 'timeFrame': '7 weeks', 'description': 'Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)'}, {'measure': 'Change in Constipation', 'timeFrame': '7 weeks', 'description': 'Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)'}, {'measure': 'Change in Belly Pain', 'timeFrame': '7 weeks', 'description': 'Difference between rates of change over time in belly pain score as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain)'}, {'measure': 'Minimal clinically important difference (MCID) in Gas and Bloating', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-60; where the higher scores correspond to worse gas and bloating)'}, {'measure': 'Minimal clinically important difference (MCID) in GI-related QOL', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related QOL)'}, {'measure': 'Minimal clinically important difference (MCID) in Constipation', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in constipation, as measured by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)'}, {'measure': 'Minimal clinically important difference (MCID) in Belly Pain', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in belly pain as assessed by PROMIS Belly Pain 5A (scale 2-25; where the higher scores correspond to worse belly pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GI Health']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.radiclescience.com', 'label': 'Radicle Science, Inc'}]}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.\n\nEligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.\n\nParticipants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.\n\nSelf-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n\n o Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed\n* Resides in the United States\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\nExclusion Criteria:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English\n* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.\n\n o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n o Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products\n* Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk\n* Lack of reliable daily access to the internet'}, 'identificationModule': {'nctId': 'NCT07130058', 'briefTitle': 'Radicle GI HealthTM RCA: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radicle Science'}, 'officialTitle': 'Radicle GI HealthTM RCA: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes', 'orgStudyIdInfo': {'id': 'RADX-P-2407_RCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'GI Health Product Form - Control', 'interventionNames': ['Dietary Supplement: GI Product Form - Control']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product', 'description': 'GI Health Product Form - Active', 'interventionNames': ['Dietary Supplement: GI Health Product Form - Active']}], 'interventions': [{'name': 'GI Product Form - Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their GI Health Product Form - Control as directed for a period of 6 weeks', 'armGroupLabels': ['Placebo Control']}, {'name': 'GI Health Product Form - Active', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their GI Health Product Form - Active as directed for a period of 6 weeks', 'armGroupLabels': ['Active Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92014', 'city': 'Del Mar', 'state': 'California', 'country': 'United States', 'facility': 'Radicle Science, Inc', 'geoPoint': {'lat': 32.95949, 'lon': -117.26531}}], 'overallOfficials': [{'name': 'Susan Hewlings', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radicle Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with researchers outside of Radicle Collaborators on this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radicle Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}