CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3 enrolled
Drug / intervention
Polyethylene Glycol 3350 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04210427
NCT04210427Phase 4Completed
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Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit

St. Louis University·interventional·Posted Dec 24, 2019·Updated Aug 9, 2024

In Brief

A Phase 4 clinical trial evaluating Polyethylene Glycol 3350 and SmartPill Motility System & PillCam Patency Capsule for Cystic Fibrosis Gastrointestinal Disease. Completed, enrolled 3 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis Gastrointestinal Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 24, 2019
Enrollment StartDec 12, 2019
Primary CompletionJun 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.5 years ago

Interventions

Polyethylene Glycol 3350drug

All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks.

SmartPill Motility System & PillCam Patency Capsuledevice

Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. 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.