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NCT05821309 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
A Phase 4 study of Constipation, sponsored by Indiana University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
- 2
- Study locations
NCT05821309: Recruiting Phase 4 study of Constipation, sponsored by Indiana University.
NCT05821309 is a Phase 4 study of Constipation that is actively recruiting participants, run by Indiana University. The registered enrollment target is 65 participants, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05821309, a Phase 4 study of Constipation, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
Conditions Studied
Interventions
- DRUG PEG 3350
- DRUG PEG-3350 with electrolytes
- DRUG Glycerin
Study Locations (2)
Indiana
- IU North Hospital - Carmel
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-06-08 |
| Est. Completion | 2026-07 |
| Phase | Phase 4 |
What NCT05821309 shows while recruiting
NCT05821309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Constipation appearing as the primary indexed condition, and to 3 interventions - of which PEG 3350 is the first listed.
NCT05821309 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05821309 about?
NCT05821309 is a clinical study titled "Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen". 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 cont...
What is the current status of trial NCT05821309?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2023-06-08. Estimated completion is 2026-07.
What conditions does trial NCT05821309 study?
This clinical trial studies the following conditions: Constipation.
What interventions are being tested in trial NCT05821309?
The interventions under investigation include: PEG 3350 (DRUG), PEG-3350 with electrolytes (DRUG), Glycerin (DRUG).
Who is sponsoring clinical trial NCT05821309?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05821309 being conducted?
This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05821309's enrollment target sits among peer trials
65 27th of 54 higher than 28 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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