Inflammatory Bowel SyndromeNCT05482464
Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
A study testing Casein glycomacropeptide (CGMP) in people with Inflammatory Bowel Syndrome, run by Oregon State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Inflammatory Bowel Syndrome
- What is being tested?
- Casein glycomacropeptide (CGMP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fluent in English
- IBS diagnosis with Rome IV criteria
- People who have a primary care provider
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Inflammatory Bowel Syndrome
- Being tested
- Casein glycomacropeptide (CGMP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein glycomacropeptide (CGMP)Dietary supplement
Casein glycomacropeptide (CGMP) supplementation for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Other | 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) Receives: Dietary Supplement: Casein glycomacropeptide (CGMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
Stool sample based gut microbiome composition using 16S rRNA gene sequencing
Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing.
Measured: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- BUILD Dairy, Agropur
- Responsible party
- Principal investigator, Dave Dallas, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482464
- Sponsor's protocol ID
- IRB-2021-1186
- Status last verified
- Jul 2022
- First submitted
- 6 Apr 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05482464
- Acronym / sponsor ID
- IRB-2021-1186
- Conditions
- Inflammatory Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- BUILD Dairy, Agropur
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment
| Arm | Type | Receives |
|---|---|---|
| Casein glycomacropeptide (CGMP) | Other | Dietary Supplement: 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fluent in English
- IBS diagnosis with Rome IV criteria
- People who have a primary care provider
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casein glycomacropeptide (CGMP)Casein glycomacropeptide (CGMP) supplementation for 3 weeks | Dietary supplement | Casein glycomacropeptide (CGMP) |
Primary outcome
Measure the inflammatory markers 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
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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein glycomacropeptide (CGMP) in people with Inflammatory Bowel Syndrome, run by Oregon State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the inflammatory markers 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.