Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
Not applicable · Testing Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice… · 2 sites · Medical University of Gdansk
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM) (a drug) and Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). (a drug) as a possible treatment. Condition(s) listed: Stoma - Ileostomy, High Output Stoma and Colon Cancer.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-04-10.
- Main results expected around 2027-06 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Poland.
Main thing being measured
- difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups (from stoma creation to postoperative day 3)
In the researchers’ words
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: * 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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Stoma - Ileostomy; High Output Stoma; Colon Cancer; IBD (Inflammatory Bowel Disease); Ileus; Omeprazole |
| Lead sponsor | Medical University of Gdansk |
| Enrollment | 80 (estimated) |
| Start date | 2025-04-10 |
| Primary completion (est.) | 2027-06 |
| First posted | 2025-04-09 |
| Last updated | 2025-07-31 |
| Official title | Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial |
| ClinicalTrials.gov ID | NCT06917963 |
Interventions
- Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM) (Drug)
This intervention consists of intensified intravenous omeprazole therapy specifically designed to reduce high-output ileostomy after surgery. It includes an initial loading dose of 80 mg omeprazole administered intravenously on the day before surgery (or on the day of surgery in emergency cases), followed by a continuous treatment of 40 mg intravenously twice daily (at 6:00 AM and 6:00 PM) during … - Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). (Drug)
The control group will receive standard intravenous omeprazole therapy as per routine clinical practice for gastrointestinal prophylaxis. Participants will receive a single daily dose of 40 mg omeprazole intravenously administered at 6:00 AM during hospitalization. This standard dosing regimen serves as the comparator for assessing the efficacy of the intensified dosing regimen used in the experim…
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital | Gdynia | Poland | Recruiting |
| Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center | Gdansk, Pomeranian Voivodeship | Poland | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.