Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04186130
Other study ID # 4-2018-0904
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 13, 2018
Est. completion date November 2021

Study information

Verified date December 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Department of Urology, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Completed NCT02854150 - Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Completed NCT00378664 - Lumbar to Sacral Ventral Nerve Re-Routing Phase 2
Active, not recruiting NCT00891891 - Psychosocial Adjustment of Adolescents With Spina Bifida
Active, not recruiting NCT00031122 - Study of Genetic Risk Factors for Spina Bifida and Anencephaly N/A
Completed NCT03573726 - Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life N/A
Completed NCT03851107 - The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Recruiting NCT02938130 - The Impact of Community-based Wellness Programs on The Triple Aim N/A
Recruiting NCT02592291 - Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions N/A
Not yet recruiting NCT05784285 - Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities N/A
Completed NCT00720161 - Metformin in Children With Motor Deficit N/A
Completed NCT05861024 - Urinary Calculi After Bladder Augmentation in Children
Completed NCT05858840 - Urinary Artificial Sphincter in Children
Recruiting NCT03856034 - Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele N/A
Recruiting NCT04362592 - In-Utero Endoscopic Correction of Spina Bifida N/A
Active, not recruiting NCT05117827 - Pediatric Powered Wheelchair Standing Devices: An Exploratory Study N/A
Completed NCT03121651 - Medication Management Among Individuals With Neurodevelopmental Disabilities N/A