MicrobiotaNCT03892590
Gut Microbiota Pilot Study
An observational study of Microbiota and Metabolism, run by Armed Forces Goyang Hospital.
Trial summary
Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbiota, Metabolism
- What is being tested?
- Gut microbiota
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Mar 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable adult patient who are admitted to ICU
Who may be able to join
- Older than 17 years old
- Every patients who are admitted to ICU
Who cannot join
- With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome
- With history of immunosuppressive agents.
- Initial systolic blood pressure <100
- Initial pulse rate > 100
- Need emergent operation at brain or torso
- Need vasopressor, transfusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anaylsis of Gut Microbiota in ICU
Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.
Read the detailed description
Microbiota is known to effect metabolism. Patients in specific conditions like hypovolemic shock, sepsis might have changes in status of microbiota. This is pilot study to get status of microbiota from normal control. Stable patient who are admitted to ICU for observation will be gathered. Samples will be collected via rectal swab at time of admission and analyzed via Next generation sequencing.
- Conditions
- Microbiota, Metabolism
- Being tested
- Gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut microbiotaBiological
Status of microbiota
| Study group | Role | What they receive |
|---|---|---|
| Stable patient | Stable patients who admitted to ICU for observation. Receives: Biological: Gut microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal microbiota
Status of microbiota of stable patient in ICU
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Armed Forces Goyang Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maru Kim, The Catholic University of Korea
- Investigators
- Maru Kim, MD, PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892590
- Sponsor's protocol ID
- Gut Microbiota
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- 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 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaylsis of Gut Microbiota in ICU
- ClinicalTrials.gov ID
- NCT03892590
- Acronym / sponsor ID
- Gut Microbiota
- Conditions
- Microbiota, Metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Armed Forces Goyang HospitalOther government
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 27 Mar 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.
Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.
Detailed description
Microbiota is known to effect metabolism. Patients in specific conditions like hypovolemic shock, sepsis might have changes in status of microbiota. This is pilot study to get status of microbiota from normal control. Stable patient who are admitted to ICU for observation will be gathered. Samples will be collected via rectal swab at time of admission and analyzed via Next generation sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stable patient | – | Biological: Gut microbiotaStable patients who admitted to ICU for observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable adult patient who are admitted to ICU
Key inclusion criteria (2 listed)
- Older than 17 years old
- Every patients who are admitted to ICU
Key exclusion criteria (6 listed)
- With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome
- With history of immunosuppressive agents.
- Initial systolic blood pressure <100
- Initial pulse rate > 100
- Need emergent operation at brain or torso
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 |
|---|---|---|
| Gut microbiotaStatus of microbiota | Biological | Stable patient |
Primary outcome
Normal microbiota
Time frame: 1day
Status of microbiota of stable patient in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Microbiota
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
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.
Maru Kim, MD, PhD study chair
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiota and Metabolism, run by Armed Forces Goyang Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M Kim, MD, PhD (82318266246, maru@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal microbiota (time frame: 1day). 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 27 Mar 2019.