Phase 4
N=3
Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
Cystic Fibrosis Gastrointestinal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04210427 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change is Being Assessed: Total Intestinal Transit Time at Baseline and Two Weeks Following Initiation of Therapy — 41; 42 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Polyethylene Glycol 3350 (Drug); SmartPill Motility System & PillCam Patency Capsule (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change is Being Assessed: Total Intestinal Transit Time at Baseline and Two Weeks Following Initiation of Therapy |
41; 42 | — |
| PRIMARY Number of Participants With IBS at Baseline and 2 Weeks Post Baseline |
3; 0; 3; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- previously diagnosed with CF confirmed with genetic mutations consistent with CF
- greater than 18 years old who chose to participate in the research study
- have symptoms of constipation (constipation will be defined as stool frequency less than three times per week, Bristol stool scale form 1-2 in >25% of stools, and/or the sensation of incomplete evacuation, manual maneuvers to facilitate stools, and the sensation of blockage)
The patients enrolled are allowed to be on CFTR modulating drugs and/or receiving enteral feeding.
Exclusion Criteria
- minors ( 40
- pregnancy (this will be screened via urine pregnancy test)
- incarcerated persons
- patients with DIOS (distal intestinal obstructive syndrome)
- patients with known hypersensitivity to PEG
- persons unable to remain off the contraindicated medications.
Data sourced from ClinicalTrials.gov (NCT04210427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.