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Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Start date pushed from Sep 1, 2026 to Oct 12, 2026
  2. Minor Eligibility criteria shortened, about 38 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07828886
Lead Sponsor First Affiliated Hospital, Sun Yat-Sen University
Collaborators: Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions
(from sponsor)
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty, Immunosenescence
Related terms Colitis, Ulcerative, Frailty, Inflammatory Bowel Diseases
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov