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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 is a Phase 4 study that has completed, run by St. Louis University. The registered enrollment target is 3 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04210427
The ClinicalTrials.gov registry entry for NCT04210427 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Polyethylene Glycol 3350 is the first listed.
NCT04210427 reports 0 study locations.
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.
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