Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
NCT ID: NCT04186130
Last Updated: 2019-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2018-11-13
2021-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Control
Children over 3 years old and under 12 years without known inflammatory bowel disease or cloacal anomaly
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
12 Years
ALL
Yes
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Urology, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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4-2018-0904
Identifier Type: -
Identifier Source: org_study_id
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