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

Study Overview
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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.

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

Conditions
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Inflammatory Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Casein glycomacropeptide (CGMP)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Casein glycomacropeptide (CGMP)<br>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)<br>* Casein glycomacropeptide (CGMP) supplementation for 3 weeks<br>|

What is the study measuring?
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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 |