Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorMedical University of Gdansk
Academic / other
Locations2 sites (Gdansk, Pomeranian Voivodeship and 1 other locations)
StatusRecruiting
StartedApril 10, 2025
Main results expectedJune 2027
Study endsJuly 2027
Registry record updatedJuly 31, 2025
Trial IDNCT06917963 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.