eligibility_summary
Include: adults (≥18) with IBD per 2019 ECCO-ESGAR, biologic-naïve or judged to need infliximab, adalimumab, vedolizumab, or ustekinumab after 3 months of meds. Exclude: refusal/contraindication to these biologics, current antibiotics or probiotic/antibiotic use within 1 month, active autoimmune disease or tumors, severe oral disease, other conditions affecting IBD treatment, pregnancy/lactation, or investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study design: Observational, multi-omics profiling (single-cell transcriptomics, 16S rRNA, etc.) of IBD patients starting biologics to uncover mechanisms of primary non-response vs response. Drugs/interventions (all monoclonal antibody biologics): Infliximab (IFX) and adalimumab (ADA)—anti–TNF-α mAbs that neutralize soluble/membrane TNF and downstream NF-κB–driven inflammation, Vedolizumab (VDZ)—anti-α4β7 integrin mAb blocking gut-selective lymphocyte trafficking via α4β7–MAdCAM-1, Ustekinumab (UST)—anti–IL-12/23 p40 mAb inhibiting Th1/Th17 cytokine signaling. Targeted cells/pathways: TNF/TNFR inflammatory cascade, α4β7+ gut-homing lymphocytes (T/B), dendritic cells, IL-12/23–JAK/STAT–Th1/Th17 axis, intestinal mucosal immune and epithelial compartments, influences of gut/oral microbiota on these cell states.