Specific Aims of Study:
To determine whether misoprostol is beneficial in patients with cirrhosis with bloating
secondary to stool and gaseous distension, patient with marked symptoms that are refractory
to standard of care will receive open label Misoprostol (100mcg twice daily and increased to
200mcg twice daily based on response) before and after 2 days of treatment with the following
assessments:
Characterization of bloating and abdominal discomfort symptoms as assessed by the
Patient Assessment of Constipation (PAC-SYM) and Patient Assessment of Gastrointestinal
Symptoms (PAGI-SYM) Questionnaires composite scores and subscale scores before
Radiologic quantitation of intestinal gaseous distension as assessed by volumetric
measurement of ultra-low radiation abdominal CT scan
Impact on severity of hepatic encephalopathy scores as assessed by West Haven criteria
grading and Psychometric Hepatic Encephalopathy Score (PHES)
This study is a prospective, open-label trial comparing the efficacy of misoprostol in the
management of bloating and gaseous distension in patients with cirrhosis.
The duration of the study will be over 3 days for each enrolled patient and will include an
initial screening encounter prior to day 1 of the study period. During the screening
encounter, participants' will receive a complete history and physical including review of
treatment with standard of care treatments such as polyethylene glycol, bisacodyl, docusate,
senna, and simethicone. If symptoms are not relieved by the use of these standard of care
treatments participants will be fully screened, provided informed consent, enrolled in the
trial.
Participants will be administered the PAC-SYM, PAGI-SYM questionnaires in addition to
determination of West Haven Criteria Grade and PHES. These baseline demographics will be
collected and used as reference for comparison of post-intervention questionnaire results.
Baseline abdominal girth will also be documented. Afterwards, participants will receive a
baseline low-dose abdominal CT for the volumetric assessment of intestinal gas. Abdominal
X-ray available from CT data will be used for scoring of colonic stool burden.
Participants will be started on the study medication on day 1. On day 1, participants will
receive an initial dose of 100 micrograms of misoprostol administered orally. The patient
will be monitored for adverse effects and, if none observed, will continue 100 microgram dose
twice daily with increase to 200mcg on day 2 if symptoms not improved. All primary outcomes
will be assessed daily between morning and evening doses.
On the morning of day 3, participants will receive one dose of study drug at dose received on
day 2. After administration of the drug, participants will repeat ultra-low dose abdominal CT
and complete a final assessment with the PAC-SYM, PAGI-SYM, PHES and West Haven Grading.