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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05482464
Recruitment Status : Recruiting
First Posted : August 1, 2022
Last Update Posted : August 1, 2022
Sponsor:
Collaborators:
BUILD Dairy
Agropur
Information provided by (Responsible Party):
Dave Dallas, Oregon State University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Syndrome Dietary Supplement: Casein glycomacropeptide (CGMP) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single group assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05482464


Locations
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United States, Oregon
Milam Hall, Room 001 Recruiting
Corvallis, Oregon, United States, 97331
Contact: David C Dallas, PhD    541-737-1751    dave.dallas@oregonstate.edu   
Contact: Yunyao Qu, MS       yunyao.qu@oregonstate.edu   
Sponsors and Collaborators
Oregon State University
BUILD Dairy
Agropur
More Information
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Responsible Party: Dave Dallas, Assistant Professor, Oregon State University
ClinicalTrials.gov Identifier: NCT05482464    
Other Study ID Numbers: IRB-2021-1186
First Posted: August 1, 2022    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action