Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit

• Status: Recruiting
• Trial end date: 2022-08-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Treatments: Polyethylene glycol 3350

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 (<18 years old)

• active nicotine use or patients on nicotine replacement

• history of abdominal surgery (surgeries involving gastrointestinal luminal resection) ie small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen. Surgeries such as Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded from this study.

• history of lung transplantation or pancreas transplant

• BMI >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.