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NCT04210427 · ClinicalTrials.gov registry record · Phase 4
Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
A Phase 4 study, sponsored by St. Louis University.
- Completed
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT04210427: Completed Phase 4 study, sponsored by St. Louis University.
NCT04210427 is a Phase 4 study that has completed, run by St. Louis University. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04210427, a Phase 4 study, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
The investigators will recruit 15 patients with cystic fibrosis 18 years of age and older who present with constipation. The investigators will assess baseline motility symptoms with a survey. Patients will then ingest a SmartPill (trademark) to obtain baseline motility within the GI lumen. All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily. After two weeks of therapy, the patient will repeat the motility survey and again ingest a smart pill to assess the change in motility symptoms while on therapy.
Primary Outcome
Total intestinal transit time will be measured from the time of ingestion to time of expulsion of smartpill. Unit of measurement will be hours.
Interventions
- DRUG Polyethylene Glycol 3350
- DEVICE SmartPill Motility System & PillCam Patency Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2023-06-06 |
| Phase | Phase 4 |
What the finished NCT04210427 record still lists
NCT04210427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Polyethylene Glycol 3350 is the first listed.
NCT04210427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04210427 about?
NCT04210427 is a clinical study titled "Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit". The investigators will recruit 15 patients with cystic fibrosis 18 years of age and older who present with constipation. The investigators will assess baseline motility symptoms with a survey. Patients will then ingest a SmartPill (trademark) to obtain baseline motility within the GI lumen. All pati...
What is the current status of trial NCT04210427?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2019-12-12. Estimated completion is 2023-06-06.
What interventions are being tested in trial NCT04210427?
The interventions under investigation include: Polyethylene Glycol 3350 (DRUG), SmartPill Motility System & PillCam Patency Capsule (DEVICE).
Who is sponsoring clinical trial NCT04210427?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04210427's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 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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