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500,000 patients join massive gut disease study

NCT ID NCT05774080

Knowledge-focused Sponsor: Target PharmaSolutions, Inc. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study is following up to 500,000 adults with chronic gastrointestinal diseases like Crohn's disease, ulcerative colitis, and eosinophilic GI disease. Researchers will collect data from electronic health records and patient reports to understand how these conditions progress over time and how well current treatments work. The goal is to improve care and outcomes for people living with these long-term gut disorders.

What this could mean

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

What this could lead to
If successful, this study could help doctors better understand how chronic GI diseases progress and which treatments work best for different patients.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test new therapies. Results may take years and might not lead to immediate changes in care.

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

About 500,000 people

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

Started

Aug 2023

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.

Ages

18 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.

Disease Cohort Inclusion Criteria: * Adult\* patients at the time of enrollment with a diagnosis or major symptom of EGIDs, UC, or CD by ICD-10 code in the EHR interface Exclusion Criteria: * Death * Manual removal (sponsor or site request) * No EHR interface encounter \> 3 years. Engaged Cohort Inclusion Criteria: * Adult\* patients diagnosed and managed for these conditions invited to participate * Ability to provide written informed consent Exclusion Criteria: * Patient expressed desire to withdraw consent to complete PROs * Failure to complete PROs within 24 weeks of initial invitation * Greater than 24 months lapse of survey completion after baseline surveys completed * Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.

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Conditions

The condition(s) this trial relates to.

Crohn disease digestive system disorder eosinophilic gastrointestinal disease ulcerative colitis

As listed by the trial registrant

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

Gastrointestinal diseases

Contacts and locations

Locations

  • Atrium Health/Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.