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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
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 belowSelect...
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
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 moreSide effects data
From 2016 Phase 4 trial • 87 Patients • NCT023081243%
dizziness
3%
Headache
100%
80%
60%
40%
20%
0%
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
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
Research Study Groups:
This trial has the following groups:- Group 1: Pyridostigmine
- Group 2: Placebo
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