Status:
WITHDRAWN
Misoprostol for Bloating and Distension
Lead Sponsor:
Montefiore Medical Center
Conditions:
Distension
Gas Bloat Syndrome
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 wel...
Detailed Description
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 refrac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04768010
Start Date
August 1 2023
End Date
September 18 2023
Last Update
September 28 2023
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