Radicle GI Health DBG: A Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

ConditionsBelly Pain GI Health

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-105

SponsorRadicle Science

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 surveys (male vs female) employed, when needed

Resides in the United States

Has the opportunity for at least 30% improvement in their primary health outcome

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

GI Health Product Placebo Control
Dietary supplement
Participants will use their GI Health Product Placebo Control as directed for a period of 6 weeks
GI Health Active Product 1
Dietary supplement
Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks
GI Health Active Product 2
Dietary supplement
Participants will use their GI Health Active Product 2 as directed for a period of 6 weeks

Treatment groups

825 Participants

are divided into 3 treatment groups

Group A: GI Health Product Placebo ControlPlacebo comparator 1 intervention

Group B: GI Health Active Product 2Experimental treatment 1 intervention

Group C: GI Health Active Product 1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radicle Science

Lead sponsor

Source ClinicalTrials.gov

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