Urinary Tract InfectionsNCT04615689
The Association of Gut Microbiota With Urinary Tract Infection in Infants
An observational study of Urinary Tract Infections, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants. Read more about this study
- Who is it for?
- Ages 6 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- The collection of feces
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2021to 1 Dec 2023
- 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 6 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants hospitalized for febrile urinary tract infection. Healthy controls who visited at primary care clinic for routine check up with informed consent.
Who may be able to join
- Clinical diagnosis of febrile urinary tract infection.
- Infants
Who cannot join
- Congenital kidney disease
- Congenital heart disease
- Other metabolic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07440
About this study
This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants.
Read the detailed description
The investigators hypothesize that the gut environment reflected by intestinal microbiota influences the risk of urinary tract infection. This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants. The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces and analyze the sequencing data by QIIME2.
- Conditions
- Urinary Tract Infections
- Being tested
- The collection of feces
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The collection of fecesOther
When the infants will be diagnosed with urinary tract infection, feces will be collected. Feces will be collected from healthy infants with informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Infants with febrile urinary tract infection | The investigators will recruit infants hospitalized for acute febrile urinary tract infection. Before starting antibiotics treatment, The investigators will collect feces with the informed consents from infants' parents. Receives: Other: The collection of feces | |
| Healthy infants | The investigators will recruit healthy controls from the clinics for routine check up with the informed consents from infants' parents. Receives: Other: The collection of feces |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.
The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces and analyze the sequencing data by QIIME2. From the OTU table, the investigators will conduct the differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection, using the linear discriminant analysis and analysis of differential abundance taking sample variation into account in R program and QIIME2.
Measured: An average of 1 year, after the completion of recruitment.
Secondary outcomes (1)
The differential functional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.
The investigators will predict the functional analysis from the OTU table and compare those results between healthy controls and infants with febrile urinary tract infection, using PICRUST2 analysis.
Measured: An average of 1 year, after the completion of recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Because of the covid 19 pandemic, no patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ky Young Cho, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- KY YOUNG CHO, M.D, Ph.D, Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615689
- Sponsor's protocol ID
- Gut microbiota and UTI
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2020
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Gut Microbiota With Urinary Tract Infection in Infants
- ClinicalTrials.gov ID
- NCT04615689
- Acronym / sponsor ID
- Gut microbiota and UTI
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Because of the covid 19 pandemic, no patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Nov 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 prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants.
Detailed description
The investigators hypothesize that the gut environment reflected by intestinal microbiota influences the risk of urinary tract infection. This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants. The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces and analyze the sequencing data by QIIME2.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with febrile urinary tract infection | – | Other: The collection of fecesThe investigators will recruit infants hospitalized for acute febrile urinary tract infection. Before starting antibiotics treatment, The investigators will collect feces with the informed consents from infants' parents. |
| Healthy infants | – | Other: The collection of fecesThe investigators will recruit healthy controls from the clinics for routine check up with the informed consents from infants' parents. |
Who may qualify
- Ages
- 6 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants hospitalized for febrile urinary tract infection. Healthy controls who visited at primary care clinic for routine check up with informed consent.
Key inclusion criteria (2 listed)
- Clinical diagnosis of febrile urinary tract infection.
- Infants
Key exclusion criteria (3 listed)
- Congenital kidney disease
- Congenital heart disease
- Other metabolic disease
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 |
|---|---|---|
| The collection of fecesWhen the infants will be diagnosed with urinary tract infection, feces will be collected. Feces will be collected from healthy infants with informed consent. | Other | Healthy infants, Infants with febrile urinary tract infection |
Primary outcome
The differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.
Time frame: An average of 1 year, after the completion of recruitment.
The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces and analyze the sequencing data by QIIME2. From the OTU table, the investigators will conduct the differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection, using the linear discriminant analysis and analysis of differential abundance taking sample variation into account in R program and QIIME2.
1 secondary outcome
The differential functional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.
Time frame: An average of 1 year, after the completion of recruitment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
KY YOUNG CHO, M.D, Ph.D principal investigator
Hallym University Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Hallym University Kangnam Sacred Heart 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
The differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection. (time frame: An average of 1 year, after the completion of recruitment.). 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 31 Mar 2022.