Tests higher-dose omeprazole to reduce high output from ileostomy
Tests intensified omeprazole against standard dosing in adults with ileostomy surgery.
Key facts
- Who runs it
- Medical University of Gdansk
- Where
- Gdansk and Gdynia, PolandSee the 2 sites
- Trial code
- Registry title
- Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 10 Apr 2025
- Expected to end
- Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)
- Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).
- Record updated
- 31 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who will have surgery that creates an ileostomy. It tests whether a higher omeprazole dose lowers high stoma output.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- People scheduled for planned or emergency surgery that needs an end or loop ileostomy.
Main reasons for not taking part
- Pregnancy or breastfeeding
- Known allergy or hypersensitivity to proton pump inhibitors, including omeprazole
- Conditions that stop the daily ileostomy output from being measured accurately
- Any reason that rules out omeprazole use
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)
- Conditions preventing accurate measurement of daily ileostomy output
- Pregnancy or lactation
Where in Poland
- Department of Oncological, Transplant and General Surgery, Univeristy Clinical CenterGdansk, PolandContact: Tomasz Sylwestrzak, MDTaking people
- Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime HospitalGdynia, PolandContact: Katarzyna Suwała, MDTaking people
About the trial
What the trial wants to find out
The goal of this clinical trial is to evaluate if intensified omeprazole therapy can reduce high-output stoma (HOS) in adults undergoing ileostomy formation surgery. The main objectives of the study are:
Read full original descriptionShow less
* To assess if intensified omeprazole treatment significantly reduces mean daily ileostomy output (ml/24h) during the first three postoperative days compared to standard omeprazole treatment. * To evaluate the proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml/day) on consecutive postoperative days. * To measure the time required for stabilization of ileostomy output (<1400 ml/day maintained for three consecutive days). * To determine the incidence of dehydration-related complications, specifically electrolyte disturbances (hyponatremia, hypokalemia). * To compare the length of initial hospital stay, frequency of rehospitalizations within 30 days post-discharge, and total length of hospital stay (including rehospitalizations).
Researchers will compare 10 days intensified omeprazole treatment (loading dose of 80 mg IV followed by 40 mg IV twice daily) with standard treatment (40 mg IV once daily) to determine the effectiveness of intensified dosing in reducing ileostomy output and improving postoperative outcomes.
Participants will:
* Receive either standard or intensified intravenous omeprazole during their hospitalization and after discharge for 10 days combined. * Undergo daily measurements of ileostomy output. * Have routine laboratory assessments of electrolyte levels. * Participate in follow-up assessments up to 30 days post-discharge, conducted either through outpatient visits or telephone consultations.
The 2 groups in the trial
- Intensified Treatment ArmTreatment being tested
Participants in this group will receive intensified therapy, starting with an initial intravenous loading dose of 80 mg of omeprazole, followed by 40 mg administered intravenously twice daily (morning and evening) during hospitalization and after discharge to complete 10 days of omeprazole therapy.
Treatment: Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)
- Standard Treatment ArmExisting treatment, for comparison
Participants in this group will receive the standard therapy consisting of a single daily intravenous dose of omeprazole (40 mg), administered each morning during hospitalization.
Treatment: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
- Plain-language title
- Tests higher-dose omeprazole to reduce high output from ileostomyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 31 July 2025