Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen - Trial NCT05821309
Access comprehensive clinical trial information for NCT05821309 through Pure Global AI's free database. This Phase 4 trial is sponsored by Indiana University and is currently Not yet recruiting. The study focuses on Constipation. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
Indiana University
Timeline & Enrollment
Phase 4
Jun 01, 2023
Jul 01, 2024
Primary Outcome
Change in Fecal Microbiome at 1 month,Change in Fecal Microbiome at 4 months,Change in Fecal Microbiome at 8 months
Summary
This study will evaluate changes in the fecal microbiome in constipated pediatric patients
 before and after antegrade continence enema placement and initiation of antegrade enema
 flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a
 fecal sample. Pre-antegrade continence enema placement results will be compared to fecal
 samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and
 initiation of miralax or golytely flushes to look for changes in bacterial diversity.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05821309
Non-Device Trial