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Clinical Trials/NCT04186130
NCT04186130
Unknown
Not Applicable

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

Yonsei University1 site in 1 country40 target enrollmentNovember 13, 2018
ConditionsSpina Bifida

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spina Bifida
Sponsor
Yonsei University
Enrollment
40
Locations
1
Primary Endpoint
the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control
Last Updated
6 years ago

Overview

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

  2. 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.

Registry
clinicaltrials.gov
Start Date
November 13, 2018
End Date
November 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control

Time Frame: 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.

Study Sites (1)

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