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Can a simple topical treatment stop a common Post-Surgery complication in ulcerative colitis?

NCT ID NCT07773948

Prevention Sponsor: University Hospital, Linkoeping Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether applying 5-ASA (mesalamine) directly to the ileal pouch after surgery for ulcerative colitis can prevent pouchitis—a painful inflammation that affects more than half of patients. Adults with UC who are scheduled for pouch surgery are randomly assigned to receive either topical 5-ASA or a placebo. The study tracks how many participants develop pouchitis over two years, aiming to see if this simple preventive step can reduce the risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
topical 5-ASA (mesalamine)
What this could lead to
If effective, this could offer a simple, low-cost way to prevent pouchitis, improving quality of life for many ulcerative colitis patients after surgery.
What could go wrong
This is a phase 4 trial, but results are not yet known. The drug may not reduce pouchitis risk, and some patients may experience intolerance or side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients with UC who are planned for reconstruction with IPAA. All four Swedish units with a national license to perform restorative surgery in IBD will be recruiting patients. Exclusion Criteria: * Patients with concomitant primary sclerosing cholangitis (PSC) or previous intolerance to 5-ASA will be excluded.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis pouchitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pouchitis Ulcerative colitis (UC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Linköping University Hospital

    Linköping, 58185, Sweden

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