Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study

• Conditions: Spina Bifida

• Registration Number: NCT04186130
• Lead Sponsor: Yonsei University

Brief Summary

Purpose: In order to verify the hypothesis that the composition of intestinal microbiota in children with spina bifida is different from that of normal control, prospective comparative analysis would be performed.

Background of the study:

Spina bifida is a congenital neurological disorder, causing neurogenic bowel. It has been known that the intestinal microbiota in spinal cord injury patient was different than that of control. Changes in intestinal motility, mucous secretion, immune surveillance, and epithelial barrier permeability are possible causes of this change. As spina bifida is also related with neurogenic bowel, the investigators hypothesized that the intestinal microbiota in spina bifida is different from that of normal control.

Patients total 30 patients and 10 controls Inclusion for patients

Patients who meet following conditions:

1) Children over 3 years old and under 12 years old who have been diagnosed with spinal bifida with spinal MRI Exclusion for patients and controls

1) Children with known inflammatory bowel disease or cloacal anomaly

Statistical analysis Statistical processing for fecal samples is aimed at alpha or beta diversity using bioinformatics, and the Kruskal-Wallis test is used to compare similarities or differences between each fecal sample. Prior to statistical analysis, the relative abundance of the detected microorganisms is analyzed first, and microorganisms having a distribution less than 0.1% are excluded from the analysis, and the remaining microorganisms are analyzed in the 'genus' step.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-13
• Study First Submitted: 2019-10-16
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-02
• Last Update Submitted: 2019-12-02
• Study First Posted: 2019-12-04
• Last Update Posted: 2019-12-04
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1. Children aged 3-12 years, diagnosed with spina bifida in spinal MRI.

Exclusion Criteria

• 1. The patient has an inflammatory intestinal disease known in the colon or has a cloacal anomaly.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control	1 year	Feces are collected about 1-2 grams and stored at -80'c refrigerator. After analysis, using biometrics, statistical processing for fecal samples is aimed at alpha or beta diversity. The Kruskal-Wallis test is used to compare similarities or differences between each fecal sample. Prior to statistical analysis, the relative abundance of the detected microorganisms is analyzed first, and microorganisms having a distribution less than 0.1% are excluded from the analysis, and the remaining microorganisms are analyzed in the 'genus' step.

Trial Locations

Locations (1)

Department of Urology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of