NCT04245254

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!

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

January 25, 2020

Last Update Submit

February 9, 2021

Conditions

Irritable Bowel SyndromeIrritable BowelIrrit

Outcome Measures

Primary Outcomes (1)

  • Change in self-reported IBS symptoms

    Baseline, Week 4 and Week 10

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Single arm study. Receives collagen protein powder.

Dietary Supplement: Collagen Protien Powder

Interventions

Collagen Protien PowderDIETARY_SUPPLEMENT

Collegen Protein Powser

Intervention Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen are more affected by IBS than men.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • US based
  • self report bloating

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10003, United States

Location

Related Publications (1)

  • 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.

    PMID: 35639457DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All participants receive one brand of collegen protien powder
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm interventional study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2020

First Posted

January 28, 2020

Study Start

May 15, 2020

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)