GutMe!: IBS and Collagen Protein Powder an Interventional Study (GutMe)

February 9, 2021 updated by: ProofPilot
In this study we would like to understand how or if a food-based supplement affects gut symptoms such as bloating, stomach cramps and irregular bowel habits. Through using a digital symptom tracking app for a few weeks, you may just learn more about exactly what is triggering your symptoms!

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • ProofPilot (Virtual Study: https://p.proofpilot.com)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • US based
  • self report bloating

Exclusion Criteria:

  • vegan or vegetarian diet
  • suffering from any skin disorders
  • kidney disease
  • treated medical issues
  • glutamine sensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Single arm study. Receives collagen protein powder.
Dietary supplement: Collagen Protien Powder
Collegen Protein Powser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in self-reported IBS symptoms
Time Frame: Baseline, Week 4 and Week 10
Baseline, Week 4 and Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProofPilot

Collaborators

Qina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

January 25, 2020

First Submitted That Met QC Criteria

January 25, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2329 (Other Identifier: Saudi FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There are currently no plans to make PID available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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