Pyridostigmine for Paralytic Ileus
(PESTI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing pyridostigmine, a medication that helps muscles work better, as a treatment for patients who have developed postoperative ileus after colorectal surgery. Postoperative ileus is a condition where the intestines don't function properly after surgery. Pyridostigmine works by increasing levels of a chemical that helps muscles move, which may help the intestines work better. Pyridostigmine has been shown to help with conditions like chronic constipation.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including neostigmine, alvimopan, metoclopramide, erythromycin, methylnaltrexone, naloxegol, cisapride, and laxatives or cathartics. If you are currently using any of these, you would need to discontinue them to participate.
Is pyridostigmine safe for treating gastrointestinal issues?
Pyridostigmine has been studied for its safety in treating gastrointestinal issues, particularly after surgery, and is generally considered safe for use in humans. It works by increasing intestinal contractions, and studies have shown it to be effective in reducing the duration of postoperative ileus with no major safety concerns reported.12345
How does the drug pyridostigmine differ from other treatments for paralytic ileus?
Pyridostigmine is unique because it works by increasing the availability of acetylcholine, a chemical that enhances gut movement, through a cholinergic anti-inflammatory pathway. This mechanism is different from other treatments, as it specifically targets the underlying cause of reduced gut motility, making it a potentially effective option for speeding up recovery after abdominal surgery.12367
What data supports the effectiveness of the drug pyridostigmine for treating paralytic ileus?
Research shows that pyridostigmine, a drug that helps increase gut movement, significantly reduces the time it takes for patients to pass gas and stool after abdominal surgery compared to a placebo. In one study, 95% of patients treated with pyridostigmine responded within 24 hours, while only 50% of those given a placebo did.12358
Who Is on the Research Team?
Stefan D Holubar
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults who've had colorectal surgery and are now facing a condition called postoperative ileus, where the intestines don't move food properly causing bloating or nausea. Participants need to have normal organ function, not be pregnant or breastfeeding, and can't have other serious health issues like heart failure or bowel obstructions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either pyridostigmine or placebo every 12 hours for a maximum of 48 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment, including side effects and bowel function
Outcome Assessment
Assessment of re-operation, complications, and re-admission within 30 days post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Pyridostigmine Bromide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stefan Holubar MD MS FACS, FASCRS
Lead Sponsor