An interventional study of Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM) and Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). in Stoma - Ileostomy, High Output Stoma and Colon Cancer, sponsored by Medical University of Gdansk. Recruiting at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Treatment
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:
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:
This clinical trial investigates whether intensified omeprazole therapy can effectively reduce a condition known as high-output stoma (HOS) in adult patients undergoing ileostomy surgery. Ileostomy surgery involves creating an opening in the abdomen (stoma) to divert waste away from a diseased or surgically removed section of the intestine. After this procedure, some patients develop an excessive fluid output from the stoma, known as high-output stoma, defined as the production of more than 1400 ml of fluid per day. This excessive fluid loss can cause serious health issues, including severe dehydration, electrolyte imbalances (such as low sodium or potassium levels), nutritional deficiencies, increased risk of kidney problems, cardiovascular complications, and prolonged hospital stays.
Currently, the standard treatment for managing high-output stoma includes dietary changes, restricting fluid intake, administering anti-diarrheal medications like loperamide, and providing intravenous fluids and electrolytes. However, many patients continue to experience high stoma output despite these standard treatments.
Previous studies have suggested that proton pump inhibitors (PPIs) such as omeprazole, medications commonly used to reduce stomach acid, may help decrease the total amount of intestinal fluid produced. Omeprazole increases the pH level (reduces acidity) of the stomach contents, which might reduce irritation in the intestine and slow down fluid loss from the stoma. Although initial results are promising, current data are limited.
In this randomized clinical trial, researchers aim to determine if providing an intensified dosing regimen of omeprazole can significantly reduce ileostomy fluid output and improve clinical outcomes compared to the standard dosing. The study will include adult patients scheduled for elective or emergency ileostomy surgery.
Participants will be randomly assigned to one of two groups:
The study's primary objective is to evaluate whether the intensified omeprazole treatment reduces the average daily ileostomy fluid output in the first three days after surgery. Additional objectives include assessing how quickly stoma output stabilizes (defined as output less than 1400 ml/day for three consecutive days), comparing the incidence of dehydration-related complications such as electrolyte imbalances, evaluating differences in hospital stay duration, and monitoring the rates of rehospitalization within 30 days after discharge.
Participants in both groups will undergo daily monitoring of their ileostomy output and regular blood tests to check electrolyte levels during their hospital stay. After discharge, participants will continue to be followed for 30 days through outpatient visits or telephone consultations to monitor any further complications or health issues.
The findings of this study could provide crucial evidence regarding the benefits of intensified omeprazole therapy. If proven effective, this approach may significantly improve patient outcomes, reduce the frequency of complications associated with high-output stomas, shorten hospital stays, and lower healthcare costs related to postoperative care.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)
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.
Drug: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).
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 hospitalization and after discharge to complete 10 day therapy, distinguishing it from standard once-daily omeprazole dosing protocols typically used for gastrointestinal ulcer prophylaxis.
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 experimental group.
difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups
The primary endpoint is the difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups, after excluding patients with minimal output (\<200 ml in any POD 1-3). A clinically significant reduction in output is defined as ≥250 ml/day.
Time frame: from stoma creation to postoperative day 3
Proportion of patients meeting the criteria for high-output stoma
Proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml/day) on consecutive postoperative days.
Time frame: 1 month from stoma creation
Time to stabilization of ileostomy output
Time to stabilization of ileostomy output (defined as output consistently \<1400 ml/day for three consecutive days).
Time frame: 1 month from stoma creation
Incidence of dehydration-related complications
Incidence of dehydration-related complications (hyponatremia, hypokalemia). Hyponatremia will be evaluated by the number of hyponatremia incidents during the hospitalization and 30 days after discharge. Hypokalemia will be evaluated by the total sum of supplementation (g) needed and the number of hypokalemia incidents during the hspitalization.
Time frame: 30 days post discharge after stoma creation
Total length of hospitalization
Length of initial hospital stay (LOS - length of stay), rehospitalization rate within 30 days post-discharge, and total length of hospitalization (TLOS - total length of stay).
Time frame: 30 days post discharge after stoma creation
Plan to share: No
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