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

StatusRecruiting
PhasePhase 4
Started2023-06-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from Indiana University

Amendment history

2026-08-17
Study Status v8
Primary completion pushed: 2026-07 → 2027-07
Completion pushed: 2026-07 → 2027-07
2026-07-30
Study Status v7
Re-verified, no change to tracked fields
2025-07-01
Study Status v6
Primary completion date2025-07→2026-07
Completion date2025-07→2026-07
2024-08-29
Study Status, Study Design, Eligibility v5
Enrollment target50→65
2024-07-31
Study Status, Sponsor/Collaborators v4
Primary completion date2024-07→2025-07
Completion date2024-07→2025-07
Show 3 earlier versions
2023-11-10
Study Status, Arms and Interventions, Eligibility v3
Eligibility criteria+50 characters
[...] y for constipation History of prior gastrointestinal surgery (excluding placement of G or GJ tubes) Underlying severe GI disease unrelated to the patient's chronic constipation Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics
2023-07-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-01→confirmed 2023-06-08
Study sitesdetails revised at 2 of 2 sites
2023-05-16
Study Status, Sponsor/Collaborators v1
Start date2023-04→2023-06-01
2023-04-07
Original filing
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.
Trial Details
NCT Number NCT05821309
Lead Sponsor Indiana University
Conditions Constipation
Enrollment 65 participants
Start Date 2023-06-08
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-18