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Home test for gut inflammation could cut flares in ulcerative colitis

NCT ID NCT03549988

Disease control Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether people with ulcerative colitis can use a home stool test to catch inflammation early and prevent symptom flares. Over 700 adults in remission used a smartphone-based test kit to measure calprotectin levels. The goal was to see if this proactive monitoring reduces steroid use, hospitalizations, and surgery, while improving quality of life.

What this could mean

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

Active substance
fecal calprotectin home test kit (IBDocTM)
What this could lead to
If successful, this approach could help people with ulcerative colitis avoid symptom flares and reduce the need for steroids or hospital visits.
What could go wrong
This is a completed trial, but the intervention is a monitoring tool, not a treatment. It may not prevent flares in all patients, and results depend on how well patients use the test and follow up.

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.

Participants

726 people

The number who actually took part.

Started

Dec 2018

Finished

Dec 2025

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.

Who is studied

Study population will consist of 756 patients with Ulcerative colitis in symptomatic remission. Through the Canadian Intestinal Research Consortium (CIRC), we intent to involve a minimum of 12 sites across Canada, Europe and Australia.

Ages

19 years and older

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: * Patients age 19 years or older with Ulcerative Colitis * Symptomatic remission defined as a modified Partial Mayo score ≤ 2 with a rectal bleeding score = 0 * Able to use IBDocTM test kit which requires a smart phone with a camera and internet access to download the CalApp® which interprets the measurement * Able to give informed consent to the study protocol Exclusion Criteria: * Patients experiencing a symptomatic flare * Patients currently receiving therapy as part of a clinical trial * Pregnancy

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Pacific Gastroenterology Associates

    Vancouver, British Columbia, V6Z 2K5, Canada

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