Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)NCT07828886
Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Frailty, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty, Immunosenescence
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 30 Sep 2030
- How long will I take part?
- 104 Weeks
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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 informed consent, or consent provided by a legally authorized representative when applicable.
Who cannot join
- 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 malignancy 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 life expectancy of less than 12 months.
- Inability to obtain the core baseline variables required for the primary analyses.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immunosenescence Phenotypes and Net Clinical Benefit of Advanced Therapies in Older Adults With Inflammatory Bowel Disease: A Prospective Multicenter Observational Cohort Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty, Immunosenescence
- Keywords
- Geriatric IBD, Frailty, Advanced Therapies, Treatment Outcomes, Net Clinical Benefit, Risk Stratification
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults With IBD Initiating Advanced Therapy | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 Weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 104 Weeks
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Yun Qiu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yun Qiu, MD, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828886
- Sponsor's protocol ID
- MR-44-24-051662
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Fons AB, Asscher VER, Stuyt RJL, Baven-Pronk AMC, van der Marel S, Jacobs RJ, Haans JJL, van der Meulen-de Jong AE, Mooijaart SP, Kalisvaart KJ, Maljaars PWJ. Frailty Is Associated With All-Cause and Acute Hospitalisations During 18 Months Follow-Up in Older Patients With Inflammatory Bowel Disease. Aliment Pharmacol Ther. 2026 Jun;63(11):1495-1506. doi: 10.1111/apt.70594. Epub 2026 Mar 8.
PubMed 41795627Ananthakrishnan AN, Nguyen GC, Bernstein CN. AGA Clinical Practice Update on Management of Inflammatory Bowel Disease in Elderly Patients: Expert Review. Gastroenterology. 2021 Jan;160(1):445-451. doi: 10.1053/j.gastro.2020.08.060. Epub 2020 Oct 1. No abstract available.
PubMed 33011177Salvatori S, Venuto C, Giannarelli D, De Cristofaro E, Spagnuolo R, Carrabetta F, Balestrieri P, Baldaro F, Mignini I, Rumi G, Lavigna DI, Calvez V, Scaldaferri F, Luzza F, Cicala M, Della-Morte D, Calabrese E, Monteleone G, Marafini I. Development and validation of the IBD frailty score in a multicenter prospective cohort of IBD outpatients. Dig Liver Dis. 2026 May;58(5):638-643. doi: 10.1016/j.dld.2026.01.228. Epub 2026 Feb 20.
PubMed 41723029Calafat M, Kochar B, Ananthakrishnan AN. A Comprehensive Review of Geriatric Syndromes and Assessment in Older Adults With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2025 Jun;23(7):1088-1101. doi: 10.1016/j.cgh.2024.09.042. Epub 2025 Mar 11.
PubMed 40081635