Can immune aging blood tests predict which older IBD patients thrive on advanced therapies?

NCT ID NCT07828886

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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.
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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 Results may not be published yet.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

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Status unknown
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First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are observing 300 adults aged 60 and older with inflammatory bowel disease who are starting an advanced therapy chosen by their usual care team. The study tracks immune-aging markers such as CD4/CD8 ratio and IL-6, along with frailty and nutrition, over 52 weeks. The goal is to see whether these markers predict who achieves steroid-free remission without serious infections, hospitalizations, or surgery. The study does not assign treatment; it follows how participants fare on whatever advanced therapy they and their doctors select.

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 immune-aging and frailty markers predict who benefits from advanced IBD therapies, doctors could use low-cost blood tests to tailor treatment for older adults.
What could go wrong
This observational study cannot prove cause and effect, and its findings may not apply to all older adults with IBD. The markers may turn out to be too weak to guide treatment decisions.

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 300 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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.

Who is studied

Adults aged 60 years or older with Crohn disease, ulcerative colitis, or IBD-unclassified who are initiating a new advanced therapy as part of routine clinical care at participating tertiary IBD centers. Participants will be enrolled prospectively and followed to evaluate immunosenescence, frailty, treatment effectiveness, safety, and other clinical outcomes. Treatment selection is determined by the treating clinician and is not assigned by the study.

Ages

60 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: * Age 60 years or older, regardless of sex. Confirmed diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified based on standard clinical, endoscopic, imaging, histologic, and laboratory criteria. Planning to initiate, or having initiated within the previous 4 weeks, a new advanced therapy, including vedolizumab, ustekinumab, an anti-TNF agent, a JAK inhibitor, an S1P receptor modulator, or another approved or clinically available advanced therapy. Active IBD or a clear indication for treatment escalation at the time of advanced therapy initiation. Availability of core baseline clinical and laboratory assessments required for the study. Expected ability to complete at least 52 weeks of follow-up. Ability of the participant or legally authorized representative to understand the study and provide written informed consent. Exclusion Criteria: * Uncertain diagnosis of IBD or another condition more likely to explain intestinal inflammation. Active severe infection at enrollment, including sepsis, active tuberculosis, uncontrolled viral hepatitis, active cytomegalovirus colitis, or another serious opportunistic infection. Clinically significant acute infection within 4 weeks before enrollment that may substantially affect baseline immune-aging measurements or short-term safety assessment. Active malignancy or recent systemic treatment for malignancy, except for adequately treated low-risk cancers as judged by the investigator. Severe immunodeficiency unrelated to IBD. Expected survival of less than 12 months or another severe end-stage condition likely to interfere with follow-up or interpretation of outcomes. Inability to obtain core baseline variables within the predefined assessment window. Continuous use of the same advanced therapy for more than 4 weeks before enrollment. Participation in another interventional study that may substantially affect treatment effectiveness or safety assessment. Any other condition that, in the investigator's judgment, would make participation inappropriate or compromise follow-up or data quality.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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