Human MicrobiomePhase 1NCT04335526
A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles
A Phase 1 study testing Cholestyramine Resin in people with Human Microbiome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Cholestyramine Resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2020to 21 Oct 2020
- Phase
- Phase 1
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 19 to 50, healthy male subjects(at screening)
- Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
Who cannot join
- Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
- Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
- Serum AST(SGOT), ALT(SGPT)>2 times upper limit of normal range MDRD eGFR <80mL/min/1.73m2
- Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
- Subject who already participated in other trials in 3 months
- Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy Volunteers
This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers
- Conditions
- Human Microbiome
- Being tested
- Cholestyramine Resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholestyramine ResinDrug
Change bile acid pool by cholestyramine treatment
| Study group | Role | What they receive |
|---|---|---|
| Metformin alone | No intervention | Not described |
| Metformin with cholestyramine | Other | Not described Receives: Drug: Cholestyramine Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the maximum blood glucose concentration (Gmax)
Compare the maximum blood glucose concentration (Gmax) between meformin alone and meformin with cholestyramine
Measured: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the maximum blood glucose concentration (Gmax)
Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine
Measured: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the gut microbiome species change
Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine
Measured: Day 1/2/8/9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 May 2020
- Primary completion30 Jul 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Chung, MD, PhD, Seoul National University Hospital
- Investigators
- Chung Jae Yong, MD, PhD, Principal investigator, Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335526
- Sponsor's protocol ID
- MMP2
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee GY, Jang Y, Chung JY, Cho JY. LC-MS/MS quantification of N-lactoyl-phenylalanine and N-lactoyl-tyrosine in human plasma: method validation and clinical application to metformin administration. Transl Clin Pharmacol. 2026 Sep;34(3):172-181. doi: 10.12793/tcp.2026.34.e12. Epub 2026 Sep 7.
PubMed 42847113
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04335526
- Acronym / sponsor ID
- MMP2
- Conditions
- Human Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 6 Apr 2020 (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 clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin alone | No intervention | – |
| Metformin with cholestyramine | Other | Drug: Cholestyramine Resin |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 19 to 50, healthy male subjects(at screening)
- Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress
Key exclusion criteria (6 listed)
- Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
- Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
- Serum AST(SGOT), ALT(SGPT)>2 times upper limit of normal range MDRD eGFR <80mL/min/1.73m2
- Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
- Subject who already participated in other trials in 3 months
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 |
|---|---|---|
| Cholestyramine ResinChange bile acid pool by cholestyramine treatment | Drug | Metformin with cholestyramine |
Primary outcome
Compare the maximum blood glucose concentration (Gmax)
Time frame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the maximum blood glucose concentration (Gmax) between meformin alone and meformin with cholestyramine
Compare the maximum blood glucose concentration (Gmax)
Time frame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine
Compare the gut microbiome species change
Time frame: Day 1/2/8/9
Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine
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 17 Mar 2021.
- Derived from this study: PubMed 42847113Lee GY, Jang Y, Chung JY, Cho JY. LC-MS/MS quantification of N-lactoyl-phenylalanine and N-lactoyl-tyrosine in human plasma: method validation and clinical application to metformin administration. Transl Clin Pharmacol. 2026 Sep;34(3):172-181. doi: 10.12793/tcp.2026.34.e12. Epub 2026 Sep 7.
- Individual participant dataSharing planned: Undecided
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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.
Chung Jae Yong, MD, PhD principal investigator
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cholestyramine Resin in people with Human Microbiome, run by Seoul National University Hospital at 1 site in South Korea.
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 17 Mar 2021. 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 South Korea. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compare the maximum blood glucose concentration (Gmax) (time frame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335526, which also lists 1 linked publication.
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 17 Mar 2021.