Misoprostol for the Management of Bloating and Gaseous Distension in Patients With Cirrhosis: an Open Label Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) Questionnaire Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Misoprostol
Participants will receive 100-200 micrograms of oral misoprostol twice daily.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) Questionnaire Score
时间窗: Baseline, Day 2, and Day 3
The PAGI-SYM is a validated 20 item self-report questionnaire divided in to six domains: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Scores for each question range from 0 (none absent) to 5 (very severe). This questionnaire obtains subscale scores derived from the average scores across these six domains. The original questionnaires asks "How severe have each of these following symptoms been in the past two weeks?" For the purpose of this study, we have obtained manufacturer approval to modify the questionnaire to ask about symptoms severity in the past day.
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire Score
时间窗: Baseline, Day 1, Day 2, and Day 3
The PAC-SYM is a validated 12 item self-report questionnaire divided into abdominal, rectal, and stool domains. The questionnaire has 4 items for abdominal symptoms, 3 items for rectal symptoms, and 5 items for stool symptoms. Scores range from 0 (none or absent) to 4 (very severe). The total score is the mean of the individual item scores.The original questionnaires asks "How severe have each of these following symptoms been in the past two weeks?" For the purpose of this study, we have obtained manufacturer approval to modify the questionnaire to ask about symptoms severity in the past day.
次要结局
- Change in intestinal gas volume from baseline to post-intervention(Baseline and Day 3)
- Change in stool burden from baseline to post-intervention(Baseline and Day 3)
- Change in Abdominal Girth(Baseline, Day 1, Day 2, and Day 3)
- Change in Psychometric Hepatic Encephalopathy Score (PHES)(Baseline, Day 2, and Day 3)
- Change in Abdominal Pain(Baseline, Day 2, and Day 3)