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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05821309
The ClinicalTrials.gov registry entry for NCT05821309 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (68% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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