An interventional study of Radicle GI Health Placebo Control Form 1 and Radicle GI Health Active Study Product 1.1 Usage in Digestion, Abdominal Pain and GI Disorders, 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 2024-05-20.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes
This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
338 studies on the registry are indexed under Abdominal Pain; 55 are open to participants now.
This study's enrollment of 2,180 is above the median of 72 across 250 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain 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.
Exclusion Criteria:
GI Health Product Form 1 - control
Dietary Supplement: Radicle GI Health Placebo Control Form 1
GI Health Product Form 1 - active product 1
Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage
GI Health Product Form 2 - control
Dietary Supplement: Radicle GI Health Placebo Control Form 2
GI Health Product Form 2 - active product 1
Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage
GI Health Product Form 2 - active product 2
Dietary Supplement: Radicle GI Health Active Study Product 2.2 Usage
GI Health Product Form 3 - control
Dietary Supplement: Radicle GI Health Placebo Control Form 3
GI Health Product Form 3 - active product 1
Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.
Change in GI (Gastrointestinal) - related Quality of Life (QOL)
Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
Time frame: 6 weeks
Change in abdominal pain
Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)
Time frame: 6 weeks
Change in gas/bloating
Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)
Time frame: 6 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in GI-related QOL
Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in abdominal pain
Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
Time frame: 6 weeks
Minimal clinically important difference (MCID) in gas/bloating
Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A
Time frame: 6 weeks
Change in mood (emotional distress-depression)
Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: 6 weeks
Change in libido
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)
Time frame: 6 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 May 2024. You cannot join it, but the record below documents what was studied.
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