An observational study in Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty and Immunosenescence, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Observational
The goal of this observational study is to learn whether signs of immune aging and frailty can help predict the balance of benefits and risks of advanced therapies in adults aged 60 years or older with inflammatory bowel disease (IBD) who are starting a new advanced therapy. Treatment will be chosen by the participant's usual clinical team and will not be assigned by the study.
The main questions it aims to answer are:
Are baseline immune-aging and frailty characteristics associated with net clinical benefit at 52 weeks, defined as steroid-free clinical remission without serious infection, treatment discontinuation because of adverse events, IBD-related hospitalization, or IBD-related surgery? Can a low-cost combination of clinical and laboratory markers help identify older adults with IBD who are more likely to have favorable or unfavorable outcomes after starting advanced therapy?
Participants will:
Continue the advanced therapy selected as part of their usual clinical care. Complete study assessments of frailty, nutritional status, disease activity, and other health factors.
Have routine and study-related blood tests, including measures related to immune aging such as CD4/CD8 ratio and interleukin-6 (IL-6).
Be followed at approximately baseline, weeks 6, 14, 26, and 52, with longer-term safety follow-up planned to week 104 when feasible.
Have information collected on remission, infections, hospitalizations, surgery, treatment continuation or change, and other health outcomes.
Older adults with inflammatory bowel disease (IBD) represent a clinically heterogeneous population. Chronological age alone may not adequately reflect physiological reserve, immune competence, frailty, or vulnerability to treatment-related adverse outcomes. Immunosenescence, characterized by age-related changes in immune cell composition and chronic low-grade inflammation, may contribute to differences in both treatment effectiveness and safety among older adults receiving advanced therapies. However, prospective evidence linking clinically accessible markers of immune aging to treatment outcomes in IBD remains limited.
This prospective, multicenter observational cohort study will evaluate older adults with IBD who initiate a new advanced therapy as part of routine clinical care. Treatment selection and subsequent treatment modifications will remain entirely at the discretion of the treating clinicians and participants. The study will characterize participants using complementary domains including immune-aging markers, frailty, nutritional status, comorbidity and polypharmacy, inflammatory disease activity, and treatment exposure. Candidate immune-aging measures include the CD4/CD8 ratio, lymphocyte measures, interleukin-6, neutrophil-to-lymphocyte ratio, and other routinely available inflammatory and nutritional biomarkers.
The primary analytical objective is to determine whether baseline immunosenescence and frailty phenotypes are associated with the overall balance of effectiveness and safety after initiation of advanced therapy. The study will also assess whether these measures provide prognostic information beyond conventional clinical factors such as age, disease activity, comorbidity burden, and treatment type. Additional analyses will explore heterogeneity across different mechanisms of advanced therapy, relationships between immune aging, frailty, and nutritional status, and differences between elderly-onset IBD and IBD diagnosed earlier in life but treated during older age.
The study is intended to establish a clinically applicable framework for risk stratification in older adults with IBD and to provide prospective data for future studies of individualized treatment strategies based on biological aging and vulnerability rather than chronological age alone.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 300 is above the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 162 studies on the registry; 54 are open to participants now.
Compared within Colitis, Ulcerative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammatory Bowel Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 60 years or older. Confirmed diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified.
Planned initiation of a new advanced therapy, or initiation of the new advanced therapy within 4 weeks before enrollment.
Active inflammatory bowel disease or another clinically documented indication for treatment escalation.
Availability of the core baseline clinical and laboratory data required for the study.
Expected ability to complete at least 52 weeks of follow-up. Ability to provide written , or consent provided by a legally authorized representative when applicable.
Exclusion Criteria:
Uncertain diagnosis of inflammatory bowel disease or an alternative diagnosis that may mimic inflammatory bowel disease.
Active severe infection at enrollment, including sepsis, active tuberculosis, uncontrolled viral hepatitis, cytomegalovirus disease, or another serious opportunistic infection.
Significant acute infection within 4 weeks before enrollment that, in the investigator's judgment, could substantially affect baseline immune-aging measurements or treatment safety assessment.
Active or recent systemic anticancer treatment, except for adequately treated low-risk malignancies as permitted by the study protocol.
Severe non-IBD-related immunodeficiency. End-stage disease or another condition associated with an expected of less than 12 months.
Inability to obtain the core baseline variables required for the primary analyses.
Treatment with the same index advanced therapy for more than 4 weeks before enrollment.
Participation in an interventional clinical trial that could interfere with the study assessments or outcomes.
Any other condition that, in the investigator's judgment, would make participation inappropriate or prevent adequate follow-up.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. Advanced therapies of interest include vedolizumab, ustekinumab, anti-TNF agents, JAK inhibitors, S1P receptor modulators, and other approved or clinically available advanced therapies. Treatment selection, dosing, optimization, switching, and discontinuation are determined by the treating clinician and are not assigned by the study. Participants will be followed prospectively to evaluate treatment effectiveness, safety, frailty, immunosenescence-related characteristics, and other clinical outcomes.
Net Clinical Benefit at Week 52
Percentage of participants achieving net clinical benefit at Week 52. Net clinical benefit is defined as steroid-free clinical remission at Week 52 without any serious infection, discontinuation of the index advanced therapy due to an adverse event, IBD-related hospitalization, or IBD-related surgery during follow-up. Steroid-free clinical remission is defined as a partial Mayo score ≤2 with no individual subscore \>1 for ulcerative colitis, or a Harvey-Bradshaw Index ≤4 for Crohn disease, with no systemic corticosteroid use for at least 4 weeks before the Week 52 assessment. Participants with IBD-unclassified will be assessed according to the predominant UC- or CD-like clinical phenotype.
Time frame: 52 Weeks
Steroid-Free Clinical Remission at Week 26
Percentage of participants achieving steroid-free clinical remission at Week 26. Remission is defined as a partial Mayo score ≤2 with no individual subscore \>1 for ulcerative colitis, or a Harvey-Bradshaw Index ≤4 for Crohn disease, with no systemic corticosteroid use for at least 4 weeks before assessment.
Time frame: 26 Weeks
Steroid-Free Clinical Remission at Week 52
Percentage of participants achieving steroid-free clinical remission at Week 52, using the same disease-specific definitions as for the Week 26 assessment.
Time frame: 52 weeks
Advanced Therapy Persistence at Week 52
Percentage of participants who remain on the advanced therapy initiated at baseline at Week 52 without permanent discontinuation because of lack of effectiveness, adverse events, or patient preference. Dose escalation, interval shortening, or re-induction will not be considered treatment discontinuation.
Time frame: 52 weeks
Incidence of Serious Infection
Percentage of participants experiencing at least one serious infection, defined as an infection requiring hospitalization, intravenous antimicrobial treatment, being life-threatening, resulting in interruption of advanced therapy, or otherwise meeting criteria for a serious adverse event.
Time frame: From Baseline Through Week 52
Incidence of IBD-Related Hospitalization
Percentage of participants experiencing at least one IBD-related hospitalization during follow-up, including hospitalization related to active IBD, disease complications, infection, intestinal obstruction, bleeding, malnutrition, treatment-related adverse events, or preparation for IBD-related surgery.
Time frame: From Baseline Through Week 52
Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 26
The Inflammatory Bowel Disease (IBD) Frailty Score is a 28-item IBD-specific frailty assessment. Each item is scored 0 or 1, yielding a total score ranging from 0 to 28. Higher scores indicate greater frailty burden and therefore a worse outcome. A total score of ≥4 has been used to classify participants as frail. Change from baseline will be calculated as the Week 26 score minus the baseline score; negative values indicate improvement and positive values indicate worsening.
Time frame: Baseline and Week 26
Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 52
The Inflammatory Bowel Disease (IBD) Frailty Score is a 28-item IBD-specific frailty assessment. Each item is scored 0 or 1, yielding a total score ranging from 0 to 28. Higher scores indicate greater frailty burden and therefore a worse outcome. A total score of ≥4 has been used to classify participants as frail. Change from baseline will be calculated as the Week 52 score minus the baseline score; negative values indicate improvement and positive values indicate worsening.
Time frame: Baseline and Week 52
Change From Baseline in Clinical Frailty Scale Score at Week 52
The Clinical Frailty Scale is a clinician-rated global frailty measure ranging from 1 to 9, where 1 represents very fit and 9 represents terminally ill. Higher scores indicate greater frailty and therefore a worse outcome. Change from baseline will be calculated as the Week 52 score minus the baseline score; negative values indicate improvement and positive values indicate worsening.
Time frame: Baseline and Week 52
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request, subject to approval by the study steering committee, participating institutions, and applicable ethics and data-protection requirements. Data sharing will require an approved research proposal and, where applicable, a data use agreement.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 12 months after publication of the primary study results and available for 36 months thereafter.
Access criteria: Requests will be considered from qualified researchers for scientifically sound proposals. Access will be subject to review and approval by the study steering committee and participating institutions, compliance with applicable ethics and data-protection requirements, and completion of a data use agreement where required.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital, Sun Yat-Sen University →