Can a simple pill get your gut moving again after surgery?
NCT ID NCT05334485
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether pyridostigmine, a drug that stimulates bowel activity, can safely and effectively treat postoperative ileus—a common condition where the bowels stop working after colorectal surgery. About 50 adults who develop ileus after elective colorectal surgery will receive either pyridostigmine or a placebo, alongside standard care. Researchers will measure how quickly bowel function returns and track any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pyridostigmine bromide (a drug that stimulates bowel muscle activity)
- What this could lead to
- If it works, this could offer a safe, simple way to get the bowels moving again after colorectal surgery, shortening hospital stays.
- What could go wrong
- This is a small, early-phase trial with only 50 participants, so results may not apply to everyone. Side effects like nausea or diarrhea are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult (age 18 and over) patients with benign or malignant colonic or rectal disease who have undergone elective laparoscopic, robotic, or open colorectal resections with or without ostomy construction at our center, and subsequently developed POI, defined as symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool for at least 48 hours postoperatively and require return to NPO status after initial diet attempts with or without placement of an NGT. 2. Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both 3. ECOG Performance status \< 4 4. Laboratory evidence of normal organ function, defined as: 1. Hemoglobin ≥ 7.0 g/dL 2. WBC ≤ 20,000/mcL and ≥ 4,000/mcL 3. Platelet count ≥ 100,000/mcL or ≤ 100,000,000/mcL 4. AST (SGOT) ≤ 2.5 times the institutional upper limit of normal 5. ALT (SGPT) ≤ 2.5 times the institutional upper limit of normal 6. Total bilirubin within the upper limit of institutional normal range 7. Serum Creatinine within the upper limit of institutional normal range Exclusion Criteria: 1. Radiographic evidence of bowel obstruction 2. Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after enrollment 3. Isolated small bowel or ostomy surgery without colon or rectal resection 4. ASA score 5 5. Pregnant or breastfeeding females as PYR is classified by the FDA as a pregnancy risk category C medication with the potential for teratogenic or abortifacient effects and demonstrated secretion into breastmilk with an unknown but potential risk for adverse effects in the nursing infants 6. 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) 7. History of allergic reactions attributed to PYR or other acetylcholine esterase inhibitors 8. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Main Campus
RECRUITINGCleveland, Ohio, 44195, United States
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Other studies related to the condition(s) this trial covers.
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