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

Not Applicable

Completed

• Conditions: Inflammatory Bowel Syndrome
• Interventions: Dietary Supplement: Casein glycomacropeptide (CGMP)

• Registration Number: NCT05482464
• Lead Sponsor: Oregon State University

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-04-06
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Casein glycomacropeptide (CGMP)	Casein glycomacropeptide (CGMP)	The subjects will receive a daily oral intake of CGMP-protein-shake for 3 weeks with a 1 week wash-in and a 3 week wash-out. Intervention: Dietary Supplement: Casein glycomacropeptide (CGMP)

Primary Outcome Measures

Name	Time	Method
Measure the inflammatory markers in stool and blood using immunology multiplex assay	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
Stool sample based gut microbiome composition using 16S rRNA gene sequencing	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.

Trial Locations

Locations (1)

Milam Hall, Room 001; 🇺🇸 Corvallis, Oregon, United States