75 Day

GI Assist Intervention for Gastrointestinal Health Improvement

STUDY TITLE GI Assist Intervention for Gastrointestinal Health Improvement
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

-

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

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Study author

Darci Gross, Patrick Killen, Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol involves the use of 'GI Assist', an organic, natural dietary supplement in powder form, aimed at improving gastrointestinal symptoms. Participants will mix the powder with water every morning before breakfast. The supplement's ingredients are believed to alleviate heartburn, loose stool, and stomach upset.

Participant engagement length

75 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$40

Included products & services
Women’s Health: $158
Outcome measures

PROMIS® Scale v1.0 – Gastrointestinal Gastroesophageal Reflux 13a

PROMIS® Item Bank v1.0 – Itch-Interference Survey

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

Yes

Recruitment jurisdictions

United States, United Kingdom

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

The Intervention

Included Products & Services

Product Name: Women’s Health

Quantity included: 0

Price: $158.00

Product Description: Efforia, together with Tasso, presents the "Comprehensive Women's Health Test," assessing DHEA-S, Estradiol, Progesterone, FSH, and Luteinizing Hormone. Our non-invasive, shoulder-attached device painlessly collects a small blood sample. Slightly more expensive but far more comfortable than traditional tests, it's ideal for those who dislike needles. Just mail it back in the pre-paid envelope for thorough lab analysis. Simple, effective, and has

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Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire

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