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).

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Casein glycomacropeptide (CGMP)

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97331
      • Recruiting
      • Milam Hall, Room 001
      • Contact: David C Dallas, PhD; Phone Number: 541-737-1751; Email: dave.dallas@oregonstate.edu
      • Contact: Yunyao Qu, MS; Email: yunyao.qu@oregonstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Dietary supplement: Casein glycomacropeptide (CGMP); Casein glycomacropeptide (CGMP) supplementation for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the inflammatory markers in stool and blood using immunology multiplex assay	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	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	Change in 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

Collaborators and Investigators

• Sponsor: Oregon State University
• Collaborators: BUILD Dairy; Agropur

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: IRB-2021-1186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No