Acute pancreatitis (AP) is an inflammatory disorder that causes a considerable economic health burden. While the overall mortality is low, around 20% of patients have a complicated course of disease resulting in increased morbidity and mortality. There is an emerging body of evidence that the microbiome exerts a crucial impact on the pathophysiology and course of AP. For several decades multiple clinical and laboratory parameters have been evaluated, and complex scoring systems were developed to predict the clinical course of AP upon admission. However, the majority of scoring systems are determined after several days and achieve a sensitivity around 70% for early prediction of severe AP. Thus, continued efforts are required to investigate reliable biomarkers for the early prediction of severity in order to guide early clinical management of AP patients. We designed a multi-center, prospective clinical-translational study to test whether the orointestinal microbiome may serve as novel early predictor of the course, severity and outcome of patients with AP. We will recruit 400 AP patients and obtain buccal and rectal swabs within 72 h of admission to the hospital. Following DNA extraction, microbiome analysis will be performed using 3rd generation sequencing Oxford Nanopore Technologies (ONT) for 16S rRNA and metagenomic sequencing. Alpha- and beta-diversity will be determined and correlated to the revised Atlanta classification and additional clinical outcome parameters such as the length of hospital stay, number and type of complications, number of interventions and 30-day mortality. If AP patients show a distinct orointestinal microbiome dependent on the severity and course of the disease, microbiome sequencing could rapidly be implemented in the early clinical management of AP patients in the future. Trial registration: ClinicalTrials.gov Identifier: NCT04777812

中文翻译：

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研究方案 P-MAPS：微生物组作为急性胰腺炎严重程度的预测指标——一项前瞻性多中心转化研究

急性胰腺炎 (AP) 是一种炎症性疾病，会导致相当大的经济健康负担。虽然总体死亡率较低，但约 20% 的患者病程复杂，导致发病率和死亡率增加。越来越多的证据表明微生物组对 AP 的病理生理学和病程产生了至关重要的影响。几十年来，已经评估了多种临床和实验室参数，并开发了复杂的评分系统来预测入院时 AP 的临床过程。然而，大多数评分系统是在几天后确定的，并且对于严重 AP 的早期预测实现了大约 70% 的灵敏度。因此，需要继续努力研究用于早期预测严重程度的可靠生物标志物，以指导 AP 患者的早期临床管理。我们设计了一项多中心、前瞻性临床转化研究，以测试口腔微生物组是否可以作为 AP 患者病程、严重程度和结果的新型早期预测因子。我们将招募 400 名 AP 患者，并在入院后 72 小时内获取口腔和直肠拭子。DNA 提取后，微生物组分析将使用第三代测序牛津纳米孔技术 (ONT) 进行 16S rRNA 和宏基因组测序。将确定 Alpha 和 Beta 多样性并将其与修订后的亚特兰大分类和其他临床结果参数（例如住院时间、并发症的数量和类型、干预措施的数量和 30 天死亡率。如果 AP 患者根据疾病的严重程度和病程表现出明显的口腔微生物组，那么未来可以在 AP 患者的早期临床管理中快速实施微生物组测序。试验注册：ClinicalTrials.gov 标识符：NCT04777812