Loading search results

Outcome Measures

Primary Outcomes (1)

Change in the severity of gastrointestinal symptoms
Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 15-105; with higher scores equaling greater severity)
7 weeks

Secondary Outcomes (3)

Change in GI-related Quality of Life (QOL)
7 weeks
Change in rhinitis symptom control
7 weeks
Change in itch severity
7 weeks

Other Outcomes (4)

Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms
7 weeks
Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL)
7 weeks
Minimal clinically important difference in rhinitis symptom control
7 weeks
+1 more other outcomes

Interventions

Active GI Health Product 1Dietary supplement

Participants will use their Active GI Health Product 1 as directed for a period of 6 weeks

Active GI Health Product 1

Placebo GI Health ControlDietary supplement

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

Placebo GI Health Control

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: Eligible participants will be stratified based on sex at birth (Female or Non-Female), age (21-44, 45-64, or 65+), Histamine Intolerance Checklist score based on the number of systems affected (2 or 3-4), and health outcome score, with categories and thresholds determined according to the published scoring guidelines. Participants will then be sequentially randomized to one of the study product groups using all stratification factors collectively to promote balanced distribution across study groups. Randomization will occur only after all required enrollment steps have been completed. Following randomization, participants will receive their assigned study product along with an insert containing additional information regarding product use and study procedures.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (4)

Study Arms (2)

Active GI Health Product 1

Placebo GI Health Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Central Study Contacts

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

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (4)

Study Arms (2)

Active GI Health Product 1

Placebo GI Health Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations