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

Inflammatory Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482464
• Other study ID #: IRB-2021-1186
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: July 2022
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Casein glycomacropeptide (CGMP)
Casein glycomacropeptide (CGMP) supplementation for 3 weeks

Locations

Country	Name	City	State
United States	Milam Hall, Room 001	Corvallis	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon State University	Agropur, BUILD Dairy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the inflammatory markers in stool and blood using immunology multiplex assay	Change in levels of inflammatory markers (GM-CSF, IFN-?, IL-1ß, 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-3a/CCL20, TNF-a and TNFß) 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
Primary	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