75 Day
GI Assist Intervention for Gastrointestinal Health Improvement
STUDY TITLE | GI Assist Intervention for Gastrointestinal Health Improvement |
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Submitted under umbrella | |
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 | |
Recruitment page preview | |
Author edit | |
Informed consent |
|
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” |
No |
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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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
Logging
Logging
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