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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 30 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05482464
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oregon State University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Inflammatory Bowel Syndrome

Additional Details

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.

Arms & Interventions

Arms

Other: 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)

Interventions

Dietary Supplement: - Casein glycomacropeptide (CGMP)

Casein glycomacropeptide (CGMP) supplementation for 3 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Milam Hall, Room 001, Corvallis, Oregon

Status

Recruiting

Address

Milam Hall, Room 001

Corvallis, Oregon, 97331

Site Contact

David C Dallas, PhD

dave.dallas@oregonstate.edu

541-737-1751

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