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

Primary Purpose

Inflammatory Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Casein glycomacropeptide (CGMP)
Sponsored by
Oregon State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Bowel Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Milam Hall, Room 001Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Casein glycomacropeptide (CGMP)

Arm Description

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)

Outcomes

Primary Outcome Measures

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
Stool sample based gut microbiome composition using 16S rRNA gene sequencing
Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2022
Last Updated
July 28, 2022
Sponsor
Oregon State University
Collaborators
BUILD Dairy, Agropur
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1. Study Identification

Unique Protocol Identification Number
NCT05482464
Brief Title
Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
Official Title
Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
Collaborators
BUILD Dairy, Agropur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Casein glycomacropeptide (CGMP)
Arm Type
Other
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein glycomacropeptide (CGMP)
Intervention Description
Casein glycomacropeptide (CGMP) supplementation for 3 weeks
Primary Outcome Measure Information:
Title
Measure the inflammatory markers in stool and blood using immunology multiplex assay
Description
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
Time Frame
Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
Title
Stool sample based gut microbiome composition using 16S rRNA gene sequencing
Description
Change in 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Milam Hall, Room 001
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David C Dallas, PhD
Phone
541-737-1751
Email
dave.dallas@oregonstate.edu
First Name & Middle Initial & Last Name & Degree
Yunyao Qu, MS
Email
yunyao.qu@oregonstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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