ArticleUnited European gastroenterology journal2025
Evolution of Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials: A Clinical Trial Databank Analysis.
Article in United European gastroenterology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Proteomics-Driven Mechanistic Insights into the Anti-Inflammatory Potential of Thinned Apple Polyphenols in a DNBS-Induced Colitis Model in Mice.Journal of proteome research · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEligibility criteria in clinical trials have been criticised for being overly restrictive without clinical justification.
objectiveWe aimed to investigate the types, evolution, and current status of eligibility criteria in clinical trials for inflammatory bowel diseases (IBD).
methodsWe performed a clinical trial databank search on clinicaltrials.gov, and included all Phase 3 placebo-controlled randomised-controlled trials (RCTs) investigating biologics or small molecules as induction therapy for moderate-to-severe Crohn's disease (CD) and ulcerative colitis (UC). Eligibility criteria were analysed both quantitatively and qualitatively.
resultsFifty-nine RCTs were identified between the year 2000 and 2022 (30 for CD and 29 for UC). The median (interquartile range) number of eligibility criteria was 44 (38-49), and did not significantly change over the studied time period (p = 0.26). Qualitative analysis showed that common patient populations, such as older patients, therapy refractory patients, patients with comorbidities, prior malignancies, unclassified IBD type, ulcerative proctitis, stricturing and fistulizing CD, as well as patients with an ostomy, were often excluded. Heterogeneity in eligibility criteria across the different IBD clinical trials was found, such as for disease activity measurement, dosage of concomitant medication, wash-out period of advanced therapies, and laboratory tests.
conclusionThe median number of eligibility criteria for IBD RCTs did not significantly change over time. The eligibility criteria are however restrictive and complex, limiting the generalisability of efficacy and safety outcomes in daily practice when drugs are approved. Future research is needed to investigate the impact of broadening eligibility criteria to better encompass real-world practice.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.