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

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.

Study Overview

• Status: Unknown
• Conditions: Spina Bifida

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Urology, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
SB; Children over 3 years old and under 12 years old who have been diagnosed with spinal bifida with spinal MRI. They should not have known inflammatory bowel disease or cloacal anomaly
Control; Children over 3 years old and under 12 years without known inflammatory bowel disease or cloacal anomaly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the alpha or beta diversity of intestinal microbiota composition in children with spina bifida is different from that of normal control	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.	1 year

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: 4-2018-0904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No