Trials Sponsors Conditions Drugs Pricing

Conditions

GI Health

Outcome Measures

Primary Outcomes (1)

Change in GI-related QoL (DQLQ)
Difference between rates of change over time in DQLQ score as assessed by Digestion-associated QoL (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
7 weeks

Secondary Outcomes (3)

Change in Gas and Bloating
7 weeks
Change in Constipation
7 weeks
Change in Diarrhea
7 weeks

Other Outcomes (5)

Change in Belly Pain
7 weeks
Minimal clinical importance difference (MCID) in GI-Related Quality of Life (DQLQ)
7 weeks
Minimal clinical importance difference (MCID) in Gas and Bloating
7 weeks
+2 more other outcomes

Study Arms (2)

Placebo control

PLACEBO COMPARATOR

GI Health Product Form - Control

Dietary Supplement: GI Health Placebo Control

Active product

EXPERIMENTAL

GI Health Product Form - Active

Dietary Supplement: GI Health Active Product

Interventions

GI Health Placebo ControlDietary supplement

Participants will use their GI Health Placebo Control as directed for a period of 6 weeks.

Placebo control

GI Health Active ProductDietary supplement

Participants will use their GI Health Active Product as directed for a period of 6 weeks.

Active product

Eligibility Criteria

Age21 Years - 105 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
o Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed

Sponsors & Collaborators

Radicle Science
Industrylead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014-2605, United States

Study Officials

Susan Hewlings
Radicle Science Inc.
PRINCIPAL INVESTIGATOR

Enrollment

450 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Radicle GI Health™: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (5)

Study Arms (2)

Placebo control

Active product

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (5)

Study Arms (2)

Placebo control

Active product

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations