Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
Resides in the United States
Report histamine intolerance symptoms affecting GI health and at least one other organ/system, determined from the Histamine Intolerance Checklist
None
Parallel
Active GI Health Product 1
Dietary supplementParticipants will use their Active GI Health Product 1 as directed for a period of 6 weeks
Placebo GI Health Control
Dietary supplementParticipants 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)
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)
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.)
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)
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)
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)
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.)
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)
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