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Objective: In the TRANS–IBD clinical trial, the outcomes are measured with selected validated questionnaires. Cross-cultural and age adaptations of the Self-Efficacy Scale for adolescents and young adults (IBD–SES), the Transition Readiness Assessment Questionnaire (TRAQ), and the Self-Management and Transition Readiness Questionnaire (STARx) were performed. Methods: Linguistic and cultural adaptation was carried out with the usage of reliability coefficients (Cronbach’s α coefficients, Spearman’s rank correlation), and with confirmatory factor analysis (CFA; root Mean Square Error of Approximation [RMSEA], Comparative Fit Index [CFI], and Tucker-Lewis Index [TLI]). Results: 112 adolescents participated in the study (45.5% male, mean age 17 ± 1.98 years). CFA was acceptable in the IBD–SES and the TRAQ. Internal consistency was acceptable in IBD–SES and good in TRAQ (0.729; 0.865, respectively). Test–retest reliability was good in IBD–SES, but below the acceptable threshold in TRAQ (ρ = 0.819; ρ = 0.034). In STARx tools, RMSEA showed poor fit values, CFI and TLI were below acceptable fit values, and internal consistency was not satisfied (0.415; 0.693, respectively), while test–retest reliabilities were acceptable (ρ = 0.787; ρ = 0.788, respectively). Conclusions: Cross-cultural, age-specific adaptation was successfully completed with IBD–SES and TRAQ. Those are comparable to the original validated versions. The adaption of the STARx tools was not successful.

Background: The TRANS-IBD study examines the superiority of joint transition visits, with drug adherence and patient satisfaction among the outcome measures. Our aim was a cross-cultural, age- and disease-specific adaptation of the ‘Medication Adherence Rating Scale’ (MARS) and ‘Patient satisfaction with health care in inflammatory bowel disease questionnaire’ (CACHE) questionnaires in patients with inflammatory bowel disease (IBD). Methods: Linguistic and cultural adaptation using test and re-test procedures were performed. Internal consistency with Cronbach’s α coefficients, confirmatory factor analyses with root Mean Square Error of Approximation (RMSEA), Comparative Fit Index (CFI), and Tucker-Lewis Index (TLI) were determined. Results: A total of 122 adolescents and 164 adults completed the questionnaires (47.5% male, mean age 17 ± 1; and 29.3% male, mean age 38 ± 11, respectively). In the MARS questionnaire, Cronbach’s α scores were found good in adolescents (0.864) and acceptable in adults (0.790), while in the CACHE questionnaire, scores were rated as excellent in both populations (0.906 and 0.945, respectively). The test-retest reliabilities were satisfactory in both groups (MARS questionnaire: r = 0.814 and r = 0.780, CACHE questionnaire: r = 0.892 and r = 0.898, respectively). RMSEA showed poor fit values in the MARS questionnaire and reasonable fit values in the CAHCE questionnaire, CFI and TLI had statistically acceptable results. Conclusion: Age-and disease-specific Hungarian versions of the questionnaires were developed, which are appropriate tools for TRANS-IBD RCT and daily IBD care.

Chronic intestinal inflammation is characteristic of Inflammatory Bowel Disease (IBD) that is associated with the exaggerated infiltration of immune cells. A complex interplay of inflammatory mediators and different cell types in the colon are responsible for the maintenance of tissue homeostasis and affect pathological conditions. Gene expression alteration of colon biopsies from IBD patients and an in vivo rat model of colitis were examined by RNA-Seq and QPCR, while we used in silico methods, such as Ingenuity Pathway Analysis (IPA) application and the Immune Gene Signature (ImSig) package of R, to interpret whole transcriptome data and estimate immune cell composition of colon tissues. Transcriptome profiling of in vivo colitis model revealed the most significant activation of signaling pathways responsible for leukocyte recruitment and diapedesis. We observed significant alteration of genes related to glycosylation or sensing of danger signals and pro- and anti-inflammatory cytokines and chemokines, as well as adhesion molecules. We observed the elevated expression of genes that implies the accumulation of monocytes, macrophages, neutrophils and B cells in the inflamed colon tissue. In contrast, the rate of T-cells slightly decreased in the inflamed regions. Interestingly, natural killer and plasma cells do not show enrichment upon colon inflammation. In general, whole transcriptome analysis of the in vivo experimental model of colitis with subsequent bioinformatics analysis provided a better understanding of the dynamic changes in the colon tissue of IBD patients.

Concomitant medications may alter the effect of biological therapy in inflammatory bowel disease. The aim was to investigate the effect of proton pump inhibitors on remission rates in patients with inflammatory bowel disease treated with the gut-selective vedolizumab. Patients from the Hungarian nationwide, multicenter vedolizumab cohort were selected for post hoc analysis. Primary outcomes were the assessment of clinical response and endoscopic and clinical remission at weeks 14 and 54. Secondary outcomes were the evaluation of the combined effect of concomitant steroid therapy and other factors, such as smoking, on remission. A total of 108 patients were identified with proton pump inhibitor data from 240 patients in the original cohort. Patients on steroids without proton pump inhibitors were more likely to have a clinical response at week 14 than patients on concomitant PPI (95% vs. 67%, p = 0.005). Non-smokers with IBD treated with VDZ were more likely to develop a clinical response at week 14 than smokers, particularly those not receiving PPI compared with patients on co-administered PPI therapy (81% vs. 53%, p = 0.041, and 92% vs. 74%, p = 0.029, respectively). We found that the use of PPIs in patients treated with VDZ may impair the achievement of response in certain subgroups. Unnecessary PPI prescriptions should be avoided.