Back to results

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

Primary Purpose

Irritable Bowel Syndrome, Irritable Bowel, Irrit

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Collagen Protien Powder

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

ProofPilot (Virtual Study: https://p.proofpilot.com)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

Single arm study. Receives collagen protein powder.

Outcomes

Primary Outcome Measures

Change in self-reported IBS symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT04245254

First Posted

January 25, 2020

Last Updated

February 9, 2021

Sponsor

ProofPilot

Collaborators

Qina

1. Study Identification

Unique Protocol Identification Number

NCT04245254

Brief Title

GutMe!: IBS and Collagen Protein Powder an Interventional Study

Acronym

GutMe

Official Title

GutMe!: IBS and Collagen Protein Powder an Interventional Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

May 15, 2020 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ProofPilot

Collaborators

Qina

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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!

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome, Irritable Bowel, Irrit

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm interventional study.

Masking

None (Open Label)

Masking Description

All participants receive one brand of collegen protien powder

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Single arm study. Receives collagen protein powder.

Intervention Type

Dietary Supplement

Intervention Name(s)

Collagen Protien Powder

Intervention Description

Collegen Protein Powser

Primary Outcome Measure Information:

Title

Change in self-reported IBS symptoms

Time Frame

Baseline, Week 4 and Week 10

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women are more affected by IBS than men.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

ProofPilot (Virtual Study: https://p.proofpilot.com)

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

35639457

Citation

Abrahams M, O'Grady R, Prawitt J. Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study. JMIR Form Res. 2022 May 31;6(5):e36339. doi: 10.2196/36339.

Results Reference

derived

Learn more about this trial

GutMe!: IBS and Collagen Protein Powder an Interventional Study

We'll reach out to this number within 24 hrs