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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
CF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGIncrease in SBM frequency
There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.
Time frame: Patients will record SBM frequency over the 4-week treatment period.
Change in PAC-SYM questionnaire score
There will be a change (with use of descriptive statistics) in bowel symptoms characterized by the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire with tenapanor administration. PAC-SYM is a PRO previously used to examine constipation in pwCF. A decreased score corresponds to improvement of bowel symptoms.
Time frame: Patients will complete the PAC-SYM at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in PAC-QOL questionnaire score
There will be a change (with use of descriptive statistics) in bowel symptoms characterized by the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire with tenapanor administration. PAC-QOL is a PRO previously used to examine constipation in pwCF. A decreased score corresponds to improvement of bowel symptoms.
Time frame: Patients will complete the PAC-QOL at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in IBS-SSS questionnaire score
There will be a 50-point change in the Irritable Bowel Syndrome Scoring System - IBS-SSS (in line with recent bowel distress related literature Ford AC, Wright-Hughes A, Alderson SLet al Lancet 2023) in pwCF and CFrC receiving tenapanor.
Time frame: Patients will complete the IBS-SSS at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
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