Misoprostol for Bloating and Distension

NCT04768010 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 2021-12715
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Distension; Gas Bloat Syndrome; Constipation

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline, Day 2, and Day 3

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

  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.

  Baseline, Day 1, Day 2, and Day 3

Secondary Outcomes (5)

• 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

Study Arms (1)

Misoprostol

EXPERIMENTAL

Participants will receive 100-200 micrograms of oral misoprostol twice daily.

Drug: Misoprostol

Interventions

Misoprostol DRUG

Participants will started by receiving 100 micrograms of oral misoprostol twice daily. If adverse effects are not noted dose can be titrated up to 200 micrograms of misoprostol twice daily. Participants will receive a total of five doses.

Also known as: Cytotec (brand name)

Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

MeSH Terms

Conditions

Dilatation, Pathologic; Gas bloat syndrome; Constipation

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Samuel Sigal, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 24, 2021
• Study Start: August 1, 2023
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share