Assessing Tenapanor as a Treatment of CF-related Constipation.
Trial Parameters
Brief Summary
Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.
Eligibility Criteria
Inclusion Criteria: 1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing) 2. Meeting criteria for CFrC Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior: * Straining in at least 25% of defecations * Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form) * Sensation of incomplete evacuation more than 25% of defecations * Sensation of anorectal obstruction/blockage more than 25% of defecations * Manual disimpaction/manipulation of pelvic floor to facilitate more than 25% of defecations * Fewer than 3 spontaneous bowel movements weekly (change in stool frequency) * Loose stools rarely present without the use of laxatives 3. Willingness to avoid major dietary or lifestyle changes during study. Exclusion Criteria: 1. Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is