Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)

To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

Pediatric inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic condition associated not only with intestinal inflammation but also with reduced physical fitness, fatigue, impaired quality of life, and psychosocial difficulties. Although physical activity and physical fitness are recognized as important determinants of health in the general pediatric population, their role as modifiable prognostic factors in children and adolescents with IBD remains insufficiently studied, particularly using objective measures and longitudinal designs in hospital settings. The present hospital-based study aims to investigate the effects of physical activity and physical fitness on inflammation, clinical outcomes, and quality of life in children and adolescents with IBD. The project comprises three phases: (1) an observational cross-sectional and longitudinal assessment, (2) a randomized controlled trial (RCT) evaluating a structured physical activity intervention, and (3) a medium-term follow-up at 6-12 months. Physical activity will be assessed objectively using accelerometry and subjectively using validated questionnaires. Physical fitness will be evaluated with the ALPHA fitness battery adapted to the hospital setting, with cardiorespiratory fitness assessed by the 20-meter shuttle run test as the primary outcome of the RCT. Clinical outcomes will include objective inflammatory markers (fecal calprotectin and C-reactive protein), disease activity indices (PCDAI or PUCAI), musculoskeletal health, fatigue, cognitive functioning, and health-related quality of life. Nutritional status and dietary quality will also be assessed, and selected biological markers will be analyzed in a subsample. The RCT will examine whether a 12-week supervised physical activity program improves cardiorespiratory fitness compared with usual care, and whether changes in fitness are accompanied by improvements in inflammatory burden and patient-reported outcomes. Longitudinal analyses will explore the sustainability of these effects over time. This study will provide comprehensive, objective evidence on the role of physical activity and physical fitness as modifiable factors in pediatric IBD. The results are expected to inform clinical practice, support the integration of structured physical activity into multidisciplinary care, and contribute high-quality data for publication in international peer-reviewed journals.

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has shown greatly improved outcomes with biologic therapies. However, nearly half of patients still experience primary or secondary non-response to existing biologics. Interleukin-23 (IL-23), a member of the IL-12 cytokine family, plays a role in maintaining intestinal homeostasis but is also involved in the pathogenesis of IBD. IL-23 is a heterodimer composed of p19 and p40 subunits linked by a disulfide bond. Humanized monoclonal antibodies selectively targeting the IL-23 p19 subunit have emerged as promising therapies for IBD. Recently, selective IL-23p19 inhibitors-risankizumab (Risan) and mirikizumab-have been approved for the treatment of moderately to severely active CD and UC, respectively. In addition, these agents, along with guselkumab (Gus), are undergoing clinical trials for both CD and UC (guselkumab, gus, and mirikizumab for CD; guselkumab and risankizumab for UC). Guselkumab (Gus) and risankizumab (Risan), both targeting the IL-23 p19 subunit, have been approved in China for the treatment of CD, with guselkumab also approved for UC. However, data on the efficacy and safety of IL-23 inhibitors (IL-23i) in Chinese UC and CD patients remain limited, and evidence in Chinese IBD populations is lacking. This is a multicenter, single-arm, prospective, observational real-world study designed to evaluate the efficacy and safety of IL-23i in adult UC and CD patients in routine clinical practice in China.