The Association of Gut Microbiota With Urinary Tract Infection in Infants

Urinary Tract Infections Clinical Trial

Official title:

The Association of Gut Microbiota With Urinary Tract Infection in Infants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04615689
• Other study ID #: Gut microbiota and UTI
• Status: Withdrawn
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 15 Months

Eligibility

Inclusion Criteria:

• Clinical diagnosis of febrile urinary tract infection.

• Infants

Exclusion Criteria:

• Congenital kidney disease

• Congenital heart disease

• Other metabolic disease

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.