30 Day

Digestive Enzymes and Bloating Relief

STUDY TITLE Digestive Enzymes and Bloating Relief
Submitted under umbrella

Umbrella Protocol for Efforia Personalized Agentic Hypothesis Discovery & Experiential Proof Trials

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

Preview

Informed consent

Review

Study author

Darci Gross

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol focuses on assessing the impact of digestive enzyme supplementation on bloating relief. Participants will incorporate a daily dose of digestive enzymes into their routine to observe any changes in digestive comfort and bloating symptoms over the course of the protocol. The study aims to understand the potential relationship between digestive enzymes and reduced bloating.

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
Chamomile 400–1,600 mg/day (flower extract): $0
Outcome measures

PROMIS® Scale v1.0 – Gastrointestinal Belly Pain 5a Survey

PROMIS Scale v1.1 – Gastrointestinal Gas and Bloating 13a

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

ClinicalTrials.gov

Yes

Commitment 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

Why I created this study:

Bloating is a common, yet often overlooked, discomfort affecting adults who seek to optimize their digestive health. While folklore and social media claim digestive enzymes as a miracle cure, academic findings suggest only limited evidence for their efficacy. This study addresses the gap between myth and science by evaluating digestive enzyme supplementation's impact on bloating. It's time for credible, personalized insights into digestive wellness.

My Objective for You:

My objective is to empower you with personalized insights into how digestive enzyme supplementation could impact your bloating and digestive comfort. By participating in this study, you'll gain valuable knowledge about your body's unique responses, helping you make informed decisions about your digestive health and lifestyle choices.

Aims & Objectives:

Our aim is to evaluate the impact of daily digestive enzyme supplementation on bloating and digestive comfort in generally healthy adults. Participants will receive personalized results, revealing how these enzymes may influence their digestive health, thus enabling informed decisions on future time and financial investments.

Significance & Impact:

This study holds significance in bridging the gap between anecdotal claims and scientific evidence regarding digestive enzyme supplementation. Expected outcomes include enhanced understanding of enzyme efficacy on bloating relief, contributing to the broader knowledge of digestive health optimization. Limitations include the exclusion of individuals with specific medical conditions, ensuring results apply to healthy adults.

The Intervention

Included Products & Services

Product Name: Chamomile 400–1,600 mg/day (flower extract)

Quantity included: 0

Price: $0.00

Product Description: A calming herb commonly used for relaxation, stress relief, and digestive support.

Product Image: Chamomile 400–1,600 mg/day (flower extract)

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