Therapeutic progress in inflammatory bowel disease (IBD) has hitherto focused on reducing inflammation to minimise long-term complications. However, strategies aimed at preventing IBD and attenuating its disease course are particularly appealing. This concept is derived from accumulating evidence for an “at-risk” preclinical state and the associations linking genetic background and numerous environmental exposures to disease pathogenesis. Trials in rheumatoid arthritis and type 1 diabetes have identified interventions to delay disease onset, modify the subsequent disease course (potentially protecting against irreversible tissue and end organ damage), and prolong normal quality of life. Prevention and interception trials have major challenges compared with therapeutic trials across a number of domains, including ethical considerations, eligibility criteria, sample size, and optimal endpoints. This Review investigates important factors in designing high-quality prevention trials and evaluates the feasibility and current progress of such trials in IBD, aiming to identify therapeutic strategies for populations at risk.

中文翻译：

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炎症性肠病的预防和拦截试验：临床试验设计的国际工作组评估

迄今为止，炎症性肠病 （IBD） 的治疗进展一直集中在减少炎症以最大限度地减少长期并发症。然而，旨在预防 IBD 和减轻其病程的策略特别有吸引力。这个概念源自“高危”临床前状态的积累证据，以及将遗传背景和许多环境暴露与疾病发病机制联系起来的关联。针对类风湿性关节炎和 1 型糖尿病的试验已经确定了延缓疾病发作、改变后续病程（可能防止不可逆组织和终末器官损伤）和延长正常生活质量的干预措施。与治疗性试验相比，预防和拦截试验在许多领域都存在重大挑战，包括伦理考虑、资格标准、样本量和最佳终点。本综述调查了设计高质量预防试验的重要因素，并评估了此类 IBD 试验的可行性和当前进展，旨在确定高危人群的治疗策略。