The Association of Gut Microbiota With Urinary Tract Infection in Infants

This prospective case-control study will compare the gut microbiota between the infants with febrile urinary tract infection and healthy infants.

Study Overview

• Status: Withdrawn
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Other: The collection of feces

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 Type: Observational

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07440
    • Hallym University Kangnam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants hospitalized for febrile urinary tract infection. Healthy controls who visited at primary care clinic for routine check up with informed consent.

Description

Inclusion Criteria:

• Clinical diagnosis of febrile urinary tract infection.
• Infants

Exclusion Criteria:

• Congenital kidney disease
• Congenital heart disease
• Other metabolic disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: The collection of feces; When the infants will be diagnosed with urinary tract infection, feces will be collected. Feces will be collected from healthy infants with informed consent.
Healthy infants; The investigators will recruit healthy controls from the clinics for routine check up with the informed consents from infants' parents.	Other: The collection of feces; When the infants will be diagnosed with urinary tract infection, feces will be collected. Feces will be collected from healthy infants with informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	An average of 1 year, after the completion of recruitment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	An average of 1 year, after the completion of recruitment.

Collaborators and Investigators

• Sponsor: Hallym University Kangnam Sacred Heart Hospital
• Investigators: Principal Investigator: KY YOUNG CHO, M.D, Ph.D, Hallym University Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: Gut microbiota and UTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No