Phase 4
Completed N=3
Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
Cystic Fibrosis Gastrointestinal Disease
Source: ClinicalTrials.gov NCT04210427 ↗
Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Change is Being Assessed: Total Intestinal Transit Time at Baseline and Two Weeks Following Initiation of Therapy — 41; 42 hours
◆ Published Evidence
Highly cited
122citations · ~14 / year
Bacterial overgrowth, dysbiosis, inflammation, and dysmotility in the Cystic Fibrosis intestine.
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.
Linked Publications (5)
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Bacterial overgrowth, dysbiosis, inflammation, and dysmotility in the Cystic Fibrosis intestine.
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Gastrointestinal transit times and motility in patients with cystic fibrosis.
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Is Gastroparesis Found More Frequently in Patients with Cystic Fibrosis? A Systematic Review.
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Impaired gastric myolectrical activity in patients with cystic fibrosis.
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Electrogastrography reveals post-prandial gastric dysmotility in children with cystic fibrosis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.