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Pyridostigmine for Paralytic Ileus (PESTI Trial)

Phase 2 & 3

Waitlist Available

Led By Stefan D Holubar

Research Sponsored by Stefan Holubar MD MS FACS, FASCRS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance status < 4

Be older than 18 years old

Must not have

Patients with any of the following uncontrolled, concurrent illnesses: active or latent MG, bronco-constrictive disease (asthma/reactive airway disease), chronic obstructive lung disease (COPD), symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia including bradycardia, renal failure, hepatic failure, gastroparesis, short bowel syndrome (small bowel < 200cm), preexisting short or large bowel dysmotility or pseudo-obstruction, chronic constipation/laxative use, peritoneal carcinomatosis, and psychiatric illness/social situations that would limit compliance with study requirements

Current use of any other investigational agents including: neostigmine or other acetylcholine esterase inhibitors, alvimopan, metoclopramide, erythromycin, methylnaltrexone, naloxegol, cisapride, and laxatives or cathartics (i.e. milk of magnesia, polyethylene glycol)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-day period following surgery

Summary

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.

Who is the study for?

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.

What is being tested?

The study tests if Pyridostigmine Bromide can help with intestinal movement after surgery compared to a placebo. It's a double-blind trial, meaning neither patients nor doctors know who gets the real drug. Everyone continues standard care too.

What are the potential side effects?

Participants will report side effects using a special scale. While not detailed here, Pyridostigmine may cause muscle cramps, diarrhea, increased saliva production, and could affect heart rate among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not completely bedridden.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled illnesses like severe asthma, heart failure, or major organ failure.

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I am not currently using any experimental drugs or specific medications for digestion.

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I have had infections inside my abdomen like abscesses or leaks.

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I am allergic to certain medications for nerve and muscle function.

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I've had surgery only on my small intestine or for an ostomy, not on my colon or rectum.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-day period following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-day period following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-day period following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of pyridostigmine bromide associated side effects

Time until return of bowel function

Secondary study objectives

Number of participants requiring re-admission

Number of participants requiring re-operation

Number of participants with complications

+2 more

Side effects data

From 2016 Phase 4 trial • 87 Patients • NCT02308124

Headache

dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Midodrine Only

Midodrine + Pyridostigmine

Pyridostigmine Only

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PyridostigmineExperimental Treatment1 Intervention

Patients randomized to this group will be given 60mg of pyridostigmine bromide orally, every 12 hours. Pyridostigmine will be administered from the time of diagnosis of postoperative ileus until the return of bowel function, or for a maximum of 48 hours.

Group II: PlaceboPlacebo Group1 Intervention

Patients randomized to this group will be given starch orally, every 12 hours for a maximum of 48 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pyridostigmine Bromide

2002

Completed Phase 4

~590

0 / 6Eligibility criteria met