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Pyridostigmine for Paralytic Ileus (PESTI Trial)

Q: Are there any patients who have not yet been signed up for this research project?

<p>According to the latest information on clinicaltrials.gov, this particular trial is not currently seeking patients. The listing was originally posted on October 1st 2022 and has had 5/9/2022 as its most recent edit date. Although this study isn't looking for volunteers right now, there are 18 other trials that are actively recruiting at this time.</p>

Q: What is the purpose of this research?

<p>The primary outcome of this pyridostigmine bromide clinical trial is the incidence of associated side effects, which will be measured over a 30-day period. Secondary outcomes include time to tolerance of solid food after postoperative ileus (defined as the amount of time from diagnosis until first tolerance of solid food), number of participants requiring re-operation (defined as the number who require a re-operation for any reason during the first 30 days following initial operation), and number of participants with complications (defined as those with any type of complication or adverse event occurring within the first 30 days following surgery).</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30-day period following surgery

Awards & highlights

PESTI Trial Summary

This trial is studying whether the drug pyridostigmine can help relieve symptoms of postoperative ileus, which is a condition that can occur after surgery in the large intestine. The trial will compare the effects of pyridostigmine to a placebo, and safety will be monitored throughout.

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.Check my eligibility

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.See study design

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.

PESTI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am not completely bedridden.

PESTI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of pyridostigmine bromide associated side effects

Time until return of bowel function

Secondary outcome measures

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

dizziness

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Midodrine Only

Midodrine + Pyridostigmine

Pyridostigmine Only

PESTI 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

~610

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stefan Holubar MD MS FACS, FASCRSLead Sponsor

1 Previous Clinical Trials

Stefan D HolubarPrincipal InvestigatorThe Cleveland Clinic

Media Library

Paralytic Ileus Research Study Groups: Pyridostigmine, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients who have not yet been signed up for this research project?

"According to the latest information on clinicaltrials.gov, this particular trial is not currently seeking patients. The listing was originally posted on October 1st 2022 and has had 5/9/2022 as its most recent edit date. Although this study isn't looking for volunteers right now, there are 18 other trials that are actively recruiting at this time."

Answered by AI

What is the purpose of this research?

"The primary outcome of this pyridostigmine bromide clinical trial is the incidence of associated side effects, which will be measured over a 30-day period. Secondary outcomes include time to tolerance of solid food after postoperative ileus (defined as the amount of time from diagnosis until first tolerance of solid food), number of participants requiring re-operation (defined as the number who require a re-operation for any reason during the first 30 days following initial operation), and number of participants with complications (defined as those with any type of complication or adverse event occurring within the first 30 days following surgery)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Stefan Holubar MD MS FACS, FASCRS 2024. "Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05334485.