Clinical Trial

Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen

Recruiting Phase 4
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-04-07; most recent amendment 2025-07-01.
Status change: Not Yet Recruiting → Recruiting 2023-07-10
Trial Details
NCT Number NCT05821309
Lead Sponsor Indiana University
Conditions Constipation
Enrollment 65 participants
Start Date 2023-06-08
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-03