The Association of Gut Microbiota With Urinary Tract Infection in Infants

Withdrawn

• Conditions: Urinary Tract Infections
• Interventions: Other: The collection of feces

• Registration Number: NCT04615689
• Lead Sponsor: Hallym University Kangnam Sacred Heart Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Study Start: 2021-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Clinical diagnosis of febrile urinary tract infection.
• Infants

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with febrile urinary tract infection	The collection of feces	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.
Healthy infants	The collection of feces	The investigators will recruit healthy controls from the clinics for routine check up with the informed consents from infants' parents.

Primary Outcome Measures

Name	Time	Method
The differential compositional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.	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.

Secondary Outcome Measures

Name	Time	Method
The differential functional analysis of the gut microbiota between healthy controls and infants with febrile urinary tract infection.	An average of 1 year, after the completion of recruitment.	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.

Trial Locations

Locations (1)

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of