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Outcome Measures

Primary Outcomes (1)

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 3-60; where the higher scores correspond to worse gas and bloating)
7 weeks

Secondary Outcomes (7)

Change in Gi-related Quality of Life (QOL)
7 weeks
Change in Constipation
7 weeks
Change in Belly Pain
7 weeks
Minimal clinically important difference (MCID) in Gas and Bloating
7 weeks
Minimal clinically important difference (MCID) in GI-related QOL
7 weeks
+2 more secondary outcomes

Interventions

GI Product Form - ControlDietary supplement

Participants will use their GI Health Product Form - Control as directed for a period of 6 weeks

Placebo Control

GI Health Product Form - ActiveDietary supplement

Participants will use their GI Health Product Form - Active 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

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

Model Details: Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Radicle GI HealthTM RCA: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

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 (7)

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 (7)

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