An interventional study of GI Health Product Placebo Control and GI Health Active Product 1 in Belly Pain and GI Health, sponsored by Radicle Science. Completed at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
Radicle GI Health DBG: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible 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.
Participants 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.
Self-reported data are collected electronically from eligible participants for 6 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 64 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 contraindication and/or a significant safety risk with any of the study product ingredients.
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
GI Health Product Placebo Control
Dietary Supplement: GI Health Product Placebo Control
GI Health Active Product 2
Dietary Supplement: GI Health Active Product 2
GI Health Active Product 1
Dietary Supplement: GI Health Active Product 1
Participants will use their GI Health Product Placebo Control as directed for a period of 6 weeks
Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks
Participants will use their GI Health Active Product 2 as directed for a period of 6 weeks
Change in Belly Pain
Change in Belly Pain: 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)
Time frame: 7 weeks
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)
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 mood (emotional distress-depression)
Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in Belly Pain
Minimal clinically important difference (MCID) in Belly Pain: 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)
Time frame: 7 weeks
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)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in GI-related QOL
Minimal clinically important difference (MCID) in GI-related QOL: 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)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)
Time frame: 7 weeks
Change in feelings of anxiety
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Time frame: 7 weeks
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)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in Diarrhea
Minimal clinically important difference (MCID) in Diarrhea: Likelihood of experiencing minimal clinically important difference in diarrhea, as measured by PROMIS Diarrhea 6A scale (2-30; where the higher scores correspond to worse diarrhea)
Time frame: 7 weeks
Change in Reflux
Change in Reflux: Difference in rates of change over time in reflux score as assessed by PROMIS Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in reflux
Minimal clinically important difference (MCID) in reflux: Likelihood of experiencing minimal clinically important difference in reflux as assessed by PROMIS Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux)
Time frame: 7 weeks
Change in nausea and vomiting
Change in nausea and vomiting: Difference in rates of change over time in nausea and vomiting score as assessed by PROMIS Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting)
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 completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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