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

Oregon State University (OSU)

Status: Enrolling

Conditions: Inflammatory Bowel Syndrome

Treatments: Dietary Supplement: Casein glycomacropeptide (CGMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05482464

IRB-2021-1186

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Casein glycomacropeptide (CGMP)

Other group

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)

Treatment:

Dietary Supplement: Casein glycomacropeptide (CGMP)