An interventional study of GI Health Active Product 1 and GI Health Product Placebo Control in Gas and Bloating, Diarrhea and Constipation, 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 2026-05-28.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (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.
59 studies on the registry are indexed under Mucopolysaccharidosis IV; 21 are open to participants now.
This study's enrollment of 500 is above the median of 88 across 26 interventional studies indexed under Mucopolysaccharidosis IV.
Browse Mucopolysaccharidosis IV studies →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 Active Product 1
Dietary Supplement: GI Health Active Product 1
GI Health Product Placebo Control
Dietary Supplement: GI Health Product Placebo Control
Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks.
Participants will use their \[Product Name\] Control as directed for a period of 6 weeks
Lower GI Collective
Difference between rates of change over time in lower GI score as assessed by a composite of PROMIS Gas and Bloating 13A, Diarrhea 6A, and Constipation 9A (scale 10-134; where the higher scores correspond to worse lower GI health)
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
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
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
Minimal clinically important difference (MCID) in lower GI health
Minimal clinically important difference (MCID) in Gas and Bloating: Likelihood of experiencing minimal clinically important difference in lower GI score as assessed by a composite of PROMIS Gas and Bloating 13A, Diarrhea 6A, and Constipation 9A (scale 10-134; where the higher scores correspond to worse lower GI health)
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
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
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
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 Nov 2025. You cannot join it, but the record below documents what was studied.
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