Crohn'sUCNot yet recruiting
Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD
Observational · No treatment assigned · Sites not listed yet · First Affiliated Hospital, Sun Yat-Sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty and Immunosenescence. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 60 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-10-12 (planned).
- Main results expected around 2029-09-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- Older Adults With IBD Initiating Advanced Therapy
Main thing being measured
- Net Clinical Benefit at Week 52 (52 Weeks)
In the researchers’ words
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…
Words you might see
- Remission: a period when the disease is quiet or under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Frailty; Immunosenescence |
| Lead sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Collaborators | Sixth Affiliated Hospital, Sun Yat-sen University; Guangdong Provincial Hospital of Traditional Chinese Medicine |
| Enrollment | 300 (estimated) |
| Start date | 2026-10-12 |
| Primary completion (est.) | 2029-09-30 |
| First posted | 2026-09-18 |
| Last updated | 2026-10-13 |
| Official title | Immunosenescence Phenotypes and Net Clinical Benefit of Advanced Therapies in Older Adults With Inflammatory Bowel Disease: A Prospective Multicenter Observational Cohort Study |
| ClinicalTrials.gov ID | NCT07828886 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: 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. 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 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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.