Can immune aging blood tests predict which older IBD patients thrive on advanced therapies?
NCT ID NCT07828886
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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