CompletedNot Applicable

Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome

United States15 participantsStarted 2022-01-01

Plain-language summary

This study investigates the use of glycomacropeptide (GMP) as a means to manipulate the gut microbiome, metabolome and protein profile of subjects with irritable bowel syndrome (IBS).

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Fluent in English * IBS diagnosis with Rome IV criteria * People who have a primary care provider Exclusion Criteria: * Lactose or milk protein intolerance * Any known other gastrointestinal disease or disorder beyond IBS, or major gastrointestinal surgery * Habitual use of laxatives or antacids * Pregnant or nursing. * Use of pre or probiotics within one month prior to the study * Use of antibiotics within one month prior to the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure the inflammatory markers in stool and blood using immunology multiplex assay

Timeframe: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3

Stool sample based gut microbiome composition using 16S rRNA gene sequencing

Timeframe: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3

Trial details

NCT IDNCT05482464

SponsorOregon State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Inflammatory Bowel Syndrome trials

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measure the inflammatory markers in stool and blood using immunology multiplex assay

Timeframe: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3

Stool sample based gut microbiome composition using 16S rRNA gene sequencing

Timeframe: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3