NCT05821309

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

Name: Clinical Trial NCT05821309
Creator: Indiana University
Keywords: Constipation, PEG 3350, Phase 4, drug, clinical trial, United States of America

Indiana University·Phase 4·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Constipation
Drug/Device/Intervention: PEG 3350
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Indiana University
Location: Carmel,Indianapolis, United States of America

Timeline & enrollment

Phase: Phase 4
Start date: Jun 01, 2023
End date: Jul 01, 2024
Enrollment: 50 participants

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

ConstipationIrritable bowel syndrome with predominant constipation [IBS-C]Other laxativesPoisoning: Other laxativesOther functional intestinal disorders

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05821309
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.