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OpenTrials
Completed

NCT Number: NCT05482464

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

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).

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Milam Hall, Room 001

Corvallis, Oregon, 97331, United States

About this study

In vitro assays show that GMP strongly promotes the growth of beneficial bacteria including Bifidobacterium breve, B. bifidum, B. infantis and Lactococcus lactis. GMP also binds to pathogenic bacteria and prevents their adhesion to intestinal cells, which could prevent enteric infection. GMP also modulates the inflammatory response of key gut immune cells called macrophages. However, the extent to which daily consumption of GMP alters the gut microbiome, metabolome and protein profile of subjects with IBS remains unknown.

This study will investigate how daily GMP consumption can alter the gut microbiome, metabolome and protein profile of subjects with IBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Casein glycomacropeptide (CGMP)

Dietary Supplement

Casein glycomacropeptide (CGMP) supplementation for 3 weeks

Primary outcomes

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

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

    Change in levels of inflammatory markers (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E/IL-25, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, MIP-3α/CCL20, TNF-α and TNFβ) in stool and blood using immunology multiplex assay

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

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

    Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing.

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • Agropur
  • BUILD Dairy

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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