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NCT03355326 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis
A Phase 4 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03355326: Clinical Trial Phase 4 study, sponsored by Indiana University.
NCT03355326 is a Phase 4 study that was terminated before completion, run by Indiana University. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03355326, a Phase 4 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall, either through primary closure or with a synthetic graft when primary closure is not feasible. It has been established that bowel function after repair of gastroschisis is impaired due to the aforementioned pathological processes. Previous studies have shown that the time from surgery to attaining full nutrition through enteral means is a predictor for morbidity in this population. Therefore, numerous therapeutic interventions have been proposed to help hasten bowel function and decrease the time to tolerance of total enteral nutrition. A common, but unproven, technique is the use of glycerin suppositories to stimulate bowel function. The concept of glycerin suppositories is that stimulating colonic activity through the use of the suppository will stimulate small intestinal function. The underlying concept is that improved bowel motility and reduced time to full enteral feeds will reduce the morbidity associated with this disease. While the formation/evacuation of stools is most easily monitored, the main purpose of using these suppositories is to hasten tolerance of nutrition through enteral means. While the practice of using glycerin suppositories is common in neonates, there is no literature or best-practice guidelines advocating for (or against) their use. A single previous prospective study utilizing glycerin suppositories in premature, low birth weight neonates failed to show any benefit in improving time to tolerate full enteral feeds. At this time, this is the only study investigating the use of glycerin suppositories in any neonatal population, and due to the indications (i.e. premature and low birth weight infants without surgical disease), the findings are not applicable to neonates with gastroschisis. To the authors' knowledge, there are no previous studi
Primary Outcome
time from study start time to goal full feeds by enteral route (per oral (PO), orogastric (OG), gastrostomy tube (gtube)).
Interventions
- DRUG Glycerin Suppository
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 4 |
Why NCT03355326 stopped before completion
NCT03355326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Glycerin Suppository is the first listed.
NCT03355326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03355326 about?
NCT03355326 is a clinical study titled "Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis". Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall, either through primary closure or with a synthetic graft when primary closure is not feasible. It ...
What is the current status of trial NCT03355326?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2017-10-01. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT03355326?
The interventions under investigation include: Glycerin Suppository (DRUG).
Who is sponsoring clinical trial NCT03355326?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03355326's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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