GutMe!: IBS and Collagen Protein Powder an Interventional Study

Sponsor

ProofPilot (Industry)

Overall Status

Completed

CT.gov ID

NCT04245254

Collaborator

Qina (Other)

Enrollment

Location

Arm

7.6

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

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!

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Irritable Bowel Irrit	Dietary Supplement: Collagen Protien Powder	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm interventional study.Single arm interventional study.

Masking:

None (Open Label)

Masking Description:

All participants receive one brand of collegen protien powder

Primary Purpose:

Treatment

Official Title:

GutMe!: IBS and Collagen Protein Powder an Interventional Study

Actual Study Start Date :

May 15, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention Arm

Single arm study. Receives collagen protein powder.

Dietary Supplement: Collagen Protien Powder

Collegen Protein Powser

Outcome Measures

Primary Outcome Measures

Change in self-reported IBS symptoms [Baseline, Week 4 and Week 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProofPilot (Virtual Study: https://p.proofpilot.com)	New York	New York	United States	10003

Sponsors and Collaborators

ProofPilot
Qina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ProofPilot

ClinicalTrials.gov Identifier:

NCT04245254

Other Study ID Numbers:

2329

First Posted:

Jan 28, 2020

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Study Results

No Results Posted as of Feb 11, 2021