The Association of Gut Microbiota With Urinary Tract Infection in Infants

NCT04615689 | Withdrawn

• 1 other identifier: Gut microbiota and UTI
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

The collection of feces OTHER

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; Infants with febrile urinary tract infection

Eligibility Criteria

• Age: 6 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Clinical diagnosis of febrile urinary tract infection.
• Infants

You may not qualify if:

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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07440, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will sequence the V3-V4 of the bacterial 16SrRNA genes from the feces.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• KY YOUNG CHO, M.D, Ph.D

  Hallym University Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 4, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)