Human MicrobiomeNCT03809260
A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin
A study testing Metformin (part 1), Vancomycin and Metformin (part 2) 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 effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Metformin (part 1), Vancomycin and Metformin (part 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2018to 28 Feb 2019
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 19 to 45, 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)>1.5 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.
South Korea1 site
SNUBH Clinical trial centor
Seongnam-si, Gyeonggi-do, 03080
About this study
Official title: A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers
This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.
- Conditions
- Human Microbiome
- Being tested
- Metformin (part 1), Vancomycin, Metformin (part 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin (part 1)Drug
Also called Diabex Tab., 500 mg
1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).
VancomycinDrug
Also called Vancozin cap., 250 mg
11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid
Metformin (part 2)Drug
Also called Diabex Tab., 500 mg
1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Metformin/Vancomycin Receives: Drug: Metformin (part 1); Drug: Vancomycin |
| Part 2 | Experimental | Metformin Receives: Drug: Metformin (part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the gut microbiome species change
Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing
Measured: Day 1/4/16/19
Secondary outcomes (4)
Compare the maximum plasma concentration (Cmax) of metformin
Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment
Measured: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
Compare the area under the plasma concentration versus time curve (AUC) of metformin
Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment
Measured: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
Compare the maximum blood glucose concentration (Gmax)
Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment
Measured: Day 1/4/16/19 (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)
Oral glucose tolerance test (OGTT); Compare the area under the blood glucose concentration versus time curve (AUC) before and after metformin (or vancomycin) PO treatment
Measured: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Dec 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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 Bundang Hospital
- Investigators
- Jae-Yong Chung, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809260
- Sponsor's protocol ID
- MMP
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31.
PubMed 33982376
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03809260
- Acronym / sponsor ID
- MMP
- Conditions
- Human Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 18 Jan 2019 (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 effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Metformin (part 1), Drug: VancomycinMetformin/Vancomycin |
| Part 2 | Experimental | Drug: Metformin (part 2)Metformin |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 19 to 45, 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 (7 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)>1.5 times upper limit of normal range
- MDRD eGFR <80mL/min/1.73m2
- Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
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 |
|---|---|---|
| Metformin (part 1)Also: Diabex Tab., 500 mg1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch). | Drug | Part 1 |
| VancomycinAlso: Vancozin cap., 250 mg11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid | Drug | Part 1 |
| Metformin (part 2)Also: Diabex Tab., 500 mg1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch) | Drug | Part 2 |
Primary outcome
Compare the gut microbiome species change
Time frame: Day 1/4/16/19
Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing
4 secondary outcomes
Compare the maximum plasma concentration (Cmax) of metformin
Time frame: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
Compare the area under the plasma concentration versus time curve (AUC) of metformin
Time frame: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
Compare the maximum blood glucose concentration (Gmax)
Time frame: Day 1/4/16/19 (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)
Time frame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
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 8 Oct 2020.
- Derived from this study: PubMed 33982376Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31.
- 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.
Jae-Yong Chung principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin (part 1), Vancomycin and Metformin (part 2) 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 7 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 8 Oct 2020. 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.
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 gut microbiome species change (time frame: Day 1/4/16/19). 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 NCT03809260, 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 8 Oct 2020.