Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes
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
Has the opportunity for at least 30% improvement in their primary health outcome
None
Parallel
Placebo GI Health Control
Dietary supplementParticipants will use their Placebo GI Health Control product as directed for a period of 4 weeks
Active GI Health Product
Dietary supplementParticipants will use their Active GI Health Product as directed for a period of 4 weeks
Change in Constipation
Change in Constipation: 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)
Change in Gas and Bloating
Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
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 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 7-105; with higher scores equaling greater severity)
Minimal clinically important difference (MCID) in Constipation
Minimal clinically important difference (MCID) in Constipation: 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)
Minimal clinically important difference (MCID) in Gas and Bloating
Minimal clinically important difference (MCID) in Gas and Bloating: Likelihood of experiencing minimal clinically important difference in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
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)
Change in Diarrhea
Change in Diarrhea: Difference between rates of change over time in diarrhea score as assessed by PROMIS Diarrhea 6A (scale 2-30; where the higher scores correspond to worse diarrhea)
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