Misoprostol for Bloating and Distension

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Symptoms of bloating, abdominal distension, and constipation are common in patients with cirrhosis. These symptoms may be explained by disease-associated effects in gastrointestinal physiology, as well as medication side-effects. The presence of these symptoms affect quality of life, as well as risk for encephalopathy. Misoprostol is a synthetic prostaglandin approved for the treatment prevention of NSAID-induced gastric ulcers. The drug also causes smooth muscle contraction in the gastrointestinal tract has been shown to improve colonic motility.

This study aims to assess the efficacy of misoprostol for treating bloating, distension, and constipation in patients with cirrhosis. Study participants will receive misoprostol for a duration of three days. Participants will complete pre-intervention and post-intervention symptom questionnaires and low dose abdominal computed tomography (CT) scan. These measures will be used to assess subjective symptom scores and objective measurement of intestinal gas and colonic stool. Post-intervention measures will be compared to pre-intervention measures to assess improvement of symptoms.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Age > 18 years old

• Participants who voluntarily sign and date an informed consent

• Participants who are willing to adhere to the procedures in this protocol

• Have biopsy or strong clinical evidence for the presence of cirrhosis

• Report any of the following symptoms: abdominal bloating, distension, and/or constipation (<3 bowel movements per week)

• Have failed management with standard-of-care therapies used at Montefiore Medical Center

• Have received a standard-of-care abdominal x-ray revealing gaseous distension or fecal loading

Exclusion Criteria:

• hemodialysis

• active infection

• Evidence of bowel obstruction

• Evidence of moderate or large ascites

• history of bowel surgery, uncontrolled thyroid disorders, inflammatory bowel disease

• pregnancy

• intubation during current hospitalization

• inability to provide informed consent.

• History of allergic reaction to prostaglandins

• Patients on narcotic medications besides a stable dose of methadone