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

NCT ID: NCT05482464

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group assignment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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)

Group Type OTHER

Casein glycomacropeptide (CGMP)

Intervention Type DIETARY_SUPPLEMENT

Casein glycomacropeptide (CGMP) supplementation for 3 weeks

Interventions

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Casein glycomacropeptide (CGMP)

Casein glycomacropeptide (CGMP) supplementation for 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BUILD Dairy

UNKNOWN

Sponsor Role collaborator

Agropur

UNKNOWN

Sponsor Role collaborator

Oregon State University

OTHER

Sponsor Role lead

Responsible Party

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Dave Dallas

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Milam Hall, Room 001

Corvallis, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-2021-1186

Identifier Type: -

Identifier Source: org_study_id

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