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

NCT04186130 | Unknown DMC

• 1 other identifier: 4-2018-0904
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Urology, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: December 4, 2019
• Study Start: November 13, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)