Stoma - IleostomySTOP-HOS-1NCT06917963
Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
A study testing 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 people with Stoma - Ileostomy and High Output Stoma, run by Medical University of Gdansk at 2 sites in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma - Ileostomy, High Output Stoma, Colon Cancer
- What is being tested?
- 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).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPoland
- Study dates
- 10 Apr 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Pregnancy or lactation
- Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)
- Conditions preventing accurate measurement of daily ileostomy output
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center
Gdansk, Pomeranian Voivodeship, 80952
Tomasz Sylwestrzak, MD, +48 516077708, tomasz.sylwestrzak@gumed.edu.pl
Piotr Spychalski, PhD, +48667843555, piotr.spychalski@gumed.edu.pl
- Recruiting
Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital
Gdynia, 81-519
Katarzyna Suwała, MD, 0048 513359794, ksuwala8@gmail.com
Katarzyna Suwała, MD
About this study
Official title: Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
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 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).
Read more
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.
Read the detailed description
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:
- Standard treatment group: Participants will receive the standard hospital treatment, which includes a daily intravenous dose of 40 mg omeprazole each morning.
- Intensified treatment group: Participants will receive an intensified regimen of omeprazole, starting with an initial intravenous loading dose of 80 mg, followed by 40 mg given twice daily (morning and evening) for 10 days.
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.
- Conditions
- Stoma - Ileostomy, High Output Stoma, Colon Cancer, IBD (Inflammatory Bowel Disease), Ileus, Omeprazole
- Being 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).
- Keywords
- stoma, ileostomy, high output stoma, omeprazole, ipp, colon cancer, ibd
- Medical subject headings
- Colonic Neoplasms, Inflammatory Bowel Diseases, Ileus, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 hospitalization and after discharge to complete 10 day therapy, distinguishing it from standard once-daily omeprazole dosing protocols typically used for gastrointestinal ulcer prophylaxis.
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 experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Intensified Treatment Arm | Experimental | 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. Receives: Drug: 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 Arm | Active comparator | 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. Receives: Drug: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from stoma creation to postoperative day 3
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 30 days post discharge after stoma creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start10 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stoma - IleostomyStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Sylwestrzak, Medical University of Gdansk
- Investigators
- Jarosław Kobiela, Professor, Study chair, MUG Division of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917963
- Sponsor's protocol ID
- KB/99/2025
- Acronym
- STOP-HOS-1
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeppesen PB, Staun M, Tjellesen L, Mortensen PB. Effect of intravenous ranitidine and omeprazole on intestinal absorption of water, sodium, and macronutrients in patients with intestinal resection. Gut. 1998 Dec;43(6):763-9. doi: 10.1136/gut.43.6.763.
PubMed 9824602Fujino S, Miyoshi N, Ohue M, Takahashi Y, Yasui M, Sugimura K, Akita H, Takahashi H, Kobayashi S, Yano M, Sakon M. Prediction model and treatment of high-output ileostomy in colorectal cancer surgery. Mol Clin Oncol. 2017 Sep;7(3):468-472. doi: 10.3892/mco.2017.1336. Epub 2017 Jul 19.
PubMed 28894582Lederhuber H, Massey LH, Kantola VE, Siddiqui MRS, Sayers AE, McDermott FD, Daniels IR, Smart NJ. Clinical management of high-output stoma: a systematic literature review and meta-analysis. Tech Coloproctol. 2023 Dec;27(12):1139-1154. doi: 10.1007/s10151-023-02830-1. Epub 2023 Jun 18.
PubMed 37330988Nightingale J, Woodward JM; Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006 Aug;55 Suppl 4(Suppl 4):iv1-12. doi: 10.1136/gut.2006.091108. No abstract available.
PubMed 16837533
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- STOP-HOS-1 / KB/99/2025
- Conditions
- Stoma - Ileostomy, High Output Stoma, Colon Cancer, IBD (Inflammatory Bowel Disease), Ileus, Omeprazole
- Keywords
- stoma, ileostomy, high output stoma, omeprazole, ipp, colon cancer, ibd
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Detailed description
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:
- Standard treatment group: Participants will receive the standard hospital treatment, which includes a daily intravenous dose of 40 mg omeprazole each morning.
- Intensified treatment group: Participants will receive an intensified regimen of omeprazole, starting with an initial intravenous loading dose of 80 mg, followed by 40 mg given twice daily (morning and evening) for 10 days.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified Treatment Arm | Experimental | 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 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. |
| Standard Treatment Arm | Active comparator | Drug: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)
- Conditions preventing accurate measurement of daily ileostomy output
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)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. | Drug | Intensified Treatment Arm |
| Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).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. | Drug | Standard Treatment Arm |
Primary outcome
difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups
Time frame: from stoma creation to postoperative day 3
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.
4 secondary outcomes
Proportion of patients meeting the criteria for high-output stoma
Time frame: 1 month from stoma creation
Time to stabilization of ileostomy output
Time frame: 1 month from stoma creation
Incidence of dehydration-related complications
Time frame: 30 days post discharge after stoma creation
Total length of hospitalization
Time frame: 30 days post discharge after stoma creation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 9824602Jeppesen PB, Staun M, Tjellesen L, Mortensen PB. Effect of intravenous ranitidine and omeprazole on intestinal absorption of water, sodium, and macronutrients in patients with intestinal resection. Gut. 1998 Dec;43(6):763-9. doi: 10.1136/gut.43.6.763.
- Background: PubMed 28894582Fujino S, Miyoshi N, Ohue M, Takahashi Y, Yasui M, Sugimura K, Akita H, Takahashi H, Kobayashi S, Yano M, Sakon M. Prediction model and treatment of high-output ileostomy in colorectal cancer surgery. Mol Clin Oncol. 2017 Sep;7(3):468-472. doi: 10.3892/mco.2017.1336. Epub 2017 Jul 19.
- Background: PubMed 37330988Lederhuber H, Massey LH, Kantola VE, Siddiqui MRS, Sayers AE, McDermott FD, Daniels IR, Smart NJ. Clinical management of high-output stoma: a systematic literature review and meta-analysis. Tech Coloproctol. 2023 Dec;27(12):1139-1154. doi: 10.1007/s10151-023-02830-1. Epub 2023 Jun 18.
- Background: PubMed 16837533Nightingale J, Woodward JM; Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006 Aug;55 Suppl 4(Suppl 4):iv1-12. doi: 10.1136/gut.2006.091108. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jarosław Kobiela, Professor study chair
MUG Division of General Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Stoma - Ileostomy and High Output Stoma, run by Medical University of Gdansk at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Sylwestrzak, MD (+48516077708, tomasz.sylwestrzak@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups (time frame: from stoma creation to postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917963, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.