30 Day

BPC-157 for Injury Recovery and Pain: A Citizen Science Trial

STUDY TITLE BPC-157 for Injury Recovery and Pain: A Citizen Science Trial
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

Matthew Amsden, Matthew Amsden, Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

BPC-157, discovered in the early 1990s is a peptide showing significant promise in speeding injury recovery, reducing associated pain, and thus improving quality of life. While there is a lot of anecdotal evidence, strong clinical trial data is lacking, leading to regulatory guidance that may affect availability. This trial aims to help build this data, establish efficacy and show BPC-157's strong safety profile.

Participant engagement length

30 Days

Sponsor

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

Cost to participant

$0

Included products & services
Inflammation Blood Test: $137
Oura Ring: $0
Outcome measures

PROMIS Bank v1.1 – Pain Interference

Inflammation Blood Test

Quality of Life and Health 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

This trial aims to address the paradox of widespread BPC-157 usage by directing it into a systematic and controlled clinical study using the principles of Efforia’s citizen science model. Our mission is to provide robust and scientifically rigorous data on the effects, safety, and efficacy of BPC-157 while creating a legitimate pathway for the extensive grey market for BPC-157. We seek to generate valuable data for the scientific community that could potentially inform future trials and contribute to FDA consideration and approval.

Our approach to this trial prioritizes participant safety. We will implement rigorous scientific protocols to systematically collect collect adverse events as opposed to the purely anecdotal chatroom and side conversation orientation today.

Through these stringent safety measures, this trial is designed to shed light on the true risk-benefit profile of BPC-157, providing a clearer understanding of its potential in a controlled and scientifically rigorous manner.

The primary objective of this trial is to evaluate the safety and efficacy of BPC-157 in promoting inflammation reduction and pain related injury recovery. Specific objectives include:



1. To categorically assess the safety of BPC-157 administration in humans, specifically its side effect profile and any adverse events.
2. To evaluate the efficacy of BPC-157 in pain and inflammation reduction in injury recovery, using objective measures such as blood inflammation markers and time to complete recovery, and subjective measures such as pain scores and quality of life measures.
3. To collect preliminary data for the design of future randomized controlled trials on BPC-157.
4. To evaluate any potential impact on mood and cognative health, from which may inform another trial on the impact of BPC-157’s proposed neuroprotective properties.

Hypothesis Statement

The daily administration of BPC-157 near the site of an injury could potentially accelerate the recovery process of phy

The Intervention

BPC-157, a synthetic peptide derived from a protein in the stomach, has attracted significant interest for its healing properties in animal models, showing potential in treating gastrointestinal issues, injuries, and inflammation. This peptide, consisting of 15 amino acids, is notable for its stability and resistance to degradation, enhancing its therapeutic effects. It works through mechanisms like promoting angiogenesis, modulating the nitric oxide system, and protecting against oxidative stress, which collectively contribute to its broad spectrum of healing capabilities. Despite its potential, BPC-157 faces controversy due to its unapproved status by the FDA and inclusion on the WADA Prohibited List, raising concerns about its safety and efficacy in humans. The lack of rigorous human studies and a possibly weak patent have hindered traditional clinical trial investments. Yet, the peptide's significant use and demand, propelled by endorsements from figures like Joe Rogan and within the health and fitness community, suggest a substantial grey market presence. The University of Zagreb holds its patent, indicating a unique ownership situation that complicates its development pathway. FDA concerns focus on safety and the absence of human research, contributing to debates over regulatory approaches to new therapies. Despite these hurdles, BPC-157 continues to be utilized for its perceived benefits, including tissue healing and anti-inflammatory effects. Potential side effects and drug interactions remain speculative due to limited data, with most concerns based on theoretical considerations rather than empirical evidence. The discussion around BPC-157 encapsulates broader issues in medical research and therapy development, highlighting the tension between innovation and regulatory compliance. As the medical community and regulatory bodies navigate these challenges, the future of BPC-157 and similar compounds will likely hinge on finding a balance that ensures safet

Included Products & Services

Product Name: Inflammation Blood Test

Quantity included: 3

Price: $137.00

Product Description: Efforia, in partnership with Tasso, introduces the "Inflammation" test, featuring Cortisol and hsCRP measurements. Our easy-to-use, shoulder-attached device gently collects a minimal blood sample non-invasively. Though a bit pricier, it's much more comfortable than conventional methods, ideal for those wary of needles. Just mail it back in the enclosed pre-paid envelope for analysis. Convenient, efficient, and pain-free.

Product Image:

Ingredients:

Product Safety:

Product Name: Oura Ring

Quantity included: 1

Price: $0.00

Product Description:

The Oura Ring is a piece of wearable technology designed to help you understand your body and improve your overall health. It is a small, lightweight ring that captures data from your body 24/7 and provides insights into your sleep, activity, and readiness. It is designed to be comfortable and discreet, and is made of hypoallergenic materials. The Oura Ring is a powerful tool that helps you to understand your body and make meaningful changes to your lifestyle.

Product Image:

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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Date Event Message Name
Oct 24, 2024 20:15:24 modified Modified the value of the entry Quantity
Inflammation Blood Test.
10820
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Previous entry value: 2
New entry value: 3
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