GutMe!: IBS and Collagen Protein Powder an Interventional... | NCT04245254

Studies
GutMe!: IBS and Collagen Protein Powder an Interventional Study

NCT04245254

Sponsor

ProofPilot

Status

Completed

Last Update Posted

Feb 11, 2021Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome
Irritable Bowel
Irrit

Interventions

Collagen Protien Powder

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jan 25, 2020

First Submission Date that Met QC Criteria

Jan 25, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 11, 2021Actual

Name	Class
Qina	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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!

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Arm	Experimental	Single arm study. Receives collagen protein powder.	Dietary Supplement: Collagen Protien Powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collagen Protien Powder	Dietary Supplement	Collegen Protein Powser	Intervention Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women are more affected by IBS than men.

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ProofPilot (Virtual Study: https://p.proofpilot.com)		New York	New York	10003	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35639457	Derived	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.

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases