drugset / Trial / NCT05821309

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

NCT05821309

Phase 4 Recruiting 65 enrolled Indiana University
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2023-06-08
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycerin Other / unclassified
Subject PEG-3350 with electrolytes Unknown
Subject polyethylene glycol Other / unclassified

Indications