Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD

NCT07828886 | Not Yet Recruiting

• 1 other identifier: MR-44-24-051662
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Frailty; Immunosenescence; Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Keywords

Geriatric IBD; Frailty; Advanced Therapies; Treatment Outcomes; Net Clinical Benefit; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• 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.

  52 Weeks

Secondary Outcomes (8)

• Steroid-Free Clinical Remission at Week 26

  26 Weeks

• Steroid-Free Clinical Remission at Week 52

  52 weeks

• Advanced Therapy Persistence at Week 52

  52 weeks

• Incidence of Serious Infection

  From Baseline Through Week 52

• Incidence of IBD-Related Hospitalization

  From Baseline Through Week 52

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Related Publications (4)

• 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.

  PMID: 41795627 RESULT

• Ananthakrishnan 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.

  PMID: 33011177 RESULT

• Salvatori 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.

  PMID: 41723029 RESULT

• Calafat 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.

  PMID: 40081635 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood will be collected at baseline, week 26, and week 52. Approximately 6 mL of blood will be obtained at each time point using EDTA anticoagulant and serum collection tubes. Samples will be transported at room temperature to the central laboratory or standardized local laboratory platforms for measurement of immune-aging biomarkers, including CD4/CD8 ratio, interleukin-6, neutrophil-to-lymphocyte ratio, and related laboratory parameters. No stool biospecimens will be collected specifically for this study; fecal calprotectin values will be obtained from routine clinical testing when available.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Frailty

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun Qiu, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Qiu, MD, PhD

CONTACT

+8613544476809; qyun@mail2.sysu.edu.cn

Yingfan Zhang, BSc

CONTACT

+8613342847850; zhyingf3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 104 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.