Intensified omeprazole treatment to reduce high-output stoma in ileostomy patients
Official title: Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
Run by Medical University of Gdansk · NCT06917963 · Data updated 2026-11-12
This study tests if a stronger dose of omeprazole can help adults with ileostomy surgery have less stoma output and stay out of the hospital longer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 2 sites (Gdansk, Pomeranian Voivodeship and 1 other locations) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | June 2027 |
| Study ends | July 2027 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT06917963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 years or older scheduled for ileostomy formation surgery.
✕Probably not a fit
Patients who are pregnant, lactating, or have known allergies to proton pump inhibitors will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of intensified omeprazole therapy in reducing high-output stoma (HOS) in adults undergoing ileostomy surgery. The study compares the mean daily ileostomy output between patients receiving intensified omeprazole treatment and those on standard therapy during the first three postoperative days. It also assesses the incidence of dehydration-related complications and the overall length of hospital stay. By investigating the potential benefits of omeprazole in managing excessive stoma output, the trial aims to improve patient outcomes following ileostomy procedures.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce fluid loss and related complications for patients with high-output stomas.
How similar studies have gone: Previous studies have suggested that proton pump inhibitors like omeprazole may effectively reduce intestinal fluid production, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Scheduled for elective or emergency surgery requiring end or loop ileostomy formation * Able and willing to provide written informed consent * No contraindications to omeprazole use Exclusion Criteria: * Pregnancy or lactation * Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole) * Conditions preventing accurate measurement of daily ileostomy output
Where it's running
-
Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center
Gdansk, Pomeranian Voivodeship, Poland Recruiting -
Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital
Gdynia, Poland Recruiting
Study contacts
- Study coordinator: Tomasz Sylwestrzak, MD
- Email: tomasz.sylwestrzak@gumed.edu.pl
- Phone: +48516077708
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.