WithdrawnEarly Phase 1

Misoprostol for Bloating and Distension

Stopped: After significant delays study was never initiated. No participants enrolled

0Started 2023-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) Questionnaire Score

Timeframe: Baseline, Day 2, and Day 3

Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire Score

Timeframe: Baseline, Day 1, Day 2, and Day 3

Trial details

NCT IDNCT04768010

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-18