An interventional study of Active GI Health Product 1 and Placebo GI Health Control in GI Health, sponsored by Radicle Science. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) have histamine intolerance symptoms affecting GI health and at least one other organ/system, (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.
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.
Self-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.
Radicle Science is the lead sponsor of 66 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all the following criteria:
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Exclusion
Individuals who report any of the following during screening may be excluded from participation.
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known and/or a significant safety risk with any of the study product ingredients. This may include:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active GI Health Product 1
Dietary Supplement: Active GI Health Product 1
Placebo GI Health Control
Dietary Supplement: Placebo GI Health Control
Participants will use their Active GI Health Product 1 as directed for a period of 6 weeks
Participants will use their Placebo GI Health Control as directed for a period of 6 weeks
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)
Time frame: 7 weeks
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)
Time frame: 7 weeks
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.)
Time frame: 7 weeks
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)
Time frame: 7 weeks
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)
Time frame: 7 weeks
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)
Time frame: 7 weeks
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.)
Time frame: 7 weeks
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)
Time frame: 7 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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