[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657352":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":60,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":100,"collaborators":41,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":41,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":41,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":41,"overallStatus":122,"whyStopped":41,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Change in the severity of gastrointestinal symptoms","Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 15-105; with higher scores equaling greater severity)","7 weeks",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Change in GI-related Quality of Life (QOL)","Change in GI-related Quality of Life (QOL): 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":18,"description":19,"timeFrame":12},"Change in rhinitis symptom control","Change in rhinitis symptom control: Change in control of rhinitis symptoms as assessed by the Rhinitis Control Assessment Test (RCAT) (Scores range from 6 to 30, with higher scores indicating better rhinitis symptom control.)",{"measure":21,"description":22,"timeFrame":12},"Change in itch severity","Change in the severity of itching: Difference between rates of change over time in itch severity as assessed by the Itch Severity Scale (ISS; scale 0-21; with higher scores equaling greater severity)",[24,27,30,33],{"measure":25,"description":26,"timeFrame":12},"Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms","Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms: Likelihood of experiencing minimal clinically important difference in gastrointestinal symptoms score as assessed by GSRS (scale 15-105; with higher scores equaling greater severity)",{"measure":28,"description":29,"timeFrame":12},"Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL)","Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL): Likelihood of experiencing minimal clinically important difference 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":31,"description":32,"timeFrame":12},"Minimal clinically important difference in rhinitis symptom control","Minimal clinically important difference in rhinitis symptom control: Likelihood of experiencing minimal clinically important difference in control of rhinitis symptoms as assessed by the Rhinitis Control Assessment Test (RCAT) (Scores range from 6 to 30, with higher scores indicating better rhinitis symptom control.)",{"measure":34,"description":35,"timeFrame":12},"Minimal clinically important difference (MCID) in the severity of itching","Minimal clinically important difference (MCID) in the severity of itching: Likelihood of experiencing minimal clinically important difference in itch severity as assessed by ISS (scale 0-21; with higher scores equaling greater severity)",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":41,"timePerspective":41,"maskingInfo":42},"RANDOMIZED","PARALLEL","Eligible participants will be stratified based on sex at birth (Female or Non-Female), age (21-44, 45-64, or 65+), Histamine Intolerance Checklist score based on the number of systems affected (2 or 3-4), and health outcome score, with categories and thresholds determined according to the published scoring guidelines. Participants will then be sequentially randomized to one of the study product groups using all stratification factors collectively to promote balanced distribution across study groups. Randomization will occur only after all required enrollment steps have been completed. Following randomization, participants will receive their assigned study product along with an insert containing additional information regarding product use and study procedures.","OTHER",null,{"masking":43,"maskingDescription":44,"whoMasked":45},"DOUBLE","The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.",[46,47],"PARTICIPANT","INVESTIGATOR","This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.\n\nEligible participants will (1) have histamine intolerance symptoms affecting GI health and at least one other organ\u002Fsystem, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.\n\nParticipants 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 enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.",[50,55],{"label":51,"type":52,"description":51,"interventionNames":53},"Active GI Health Product 1","EXPERIMENTAL",[54],"Dietary Supplement: Active GI Health Product 1",{"label":56,"type":57,"description":56,"interventionNames":58},"Placebo GI Health Control","PLACEBO_COMPARATOR",[59],"Dietary Supplement: Placebo GI Health Control",[61,65],{"type":62,"name":51,"description":63,"armGroupLabels":64,"otherNames":41},"DIETARY_SUPPLEMENT","Participants will use their Active GI Health Product 1 as directed for a period of 6 weeks",[51],{"type":62,"name":56,"description":66,"armGroupLabels":67,"otherNames":41},"Participants will use their Placebo GI Health Control as directed for a period of 6 weeks",[56],[69],{"name":70,"affiliation":5,"role":71},"Susan Hewlings","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":41,"email":77},"Study Manager","CONTACT","858-779-0086","studymgmt@radiclescience.com",{"name":70,"role":75,"phone":79,"phoneExt":41,"email":80},"760-281-3898","susan.hewlings@radiclescience.com",[82],{"facility":83,"status":41,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Radicle Science, Inc","Del Mar","California","92014","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-117.26531,32.95949,{"lat":93,"lon":92},[96,97],{"name":74,"role":75,"phone":79,"phoneExt":41,"email":77},{"name":98,"role":75,"phone":41,"phoneExt":41,"email":99},"Megan Moseley","megan@radiclescience.com",{"type":101,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100657352","radicle-gi-health-rfy-a-study-assessing-the-impact-of-dao-supplementation-on-gastrointestinal-and-other-histamine-intolerance-symptoms-100657352",false,"NCT07835776","Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms","Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms","Inclusion\n\nParticipants must meet all the following 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  * Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed\n* Resides in the United States\n* Report histamine intolerance symptoms affecting GI health and at least one other organ\u002Fsystem, determined from the Histamine Intolerance Checklist\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\n\nIndividuals who report any of the following during screening may be excluded from participation.\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 at a 7th grade level\n* Reports a current and\u002For recent (up to 3 months ago) major illness and\u002For 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\u002For a significant safety risk with any of the study product ingredients. This may include:\n\n  * 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. This may include:\n\n  * 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\u002For similar product(s) to the active study product(s) that may limit the effects of the study products and\u002For pose a safety risk\n* Lack of reliable daily access to the internet",true,"ALL","21 Years","105 Years",{"count":114,"type":115},550,"ESTIMATED","INTERVENTIONAL",[118],"NA","Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.",[121],"GI Health","NOT_YET_RECRUITING","2026-09-17",{"date":125,"type":126},"2026-09-23","ACTUAL",{"date":128,"type":115},"2026-10-08",{"date":130,"type":115},"2027-10-08",{"name":5,"class":6},1]