Inflammatory Bowel Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCasein glycomacropeptide (CGMP)
Casein glycomacropeptide (CGMP) supplementation for 3 weeks
Sponsors
BUILD Dairy
Agropur
Oregon State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the inflammatory markers 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 | 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 | 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. |
Countries
United States
Outcome results
None listed