Misoprostol for Bloating and Distension (NCT04768010) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) Questionnaire Score
Timeframe: Baseline, Day 2, and Day 3
2
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire Score