Data for: Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children

This dataset contains clinical information for 429 participants who were enrolled in the PBSAM trial (see protocol for more details). Participants were enrolled after meeting an inclusion criteria into the study of having at least 2 severe characteristics for an acute illness and with a severe acute malnutrition diagnosis. They were then followed up for 6 months post discharge. Data was collected in the following time-points: at admission, daily review (during hospitalization), at discharge, at 21 days after admission and finally 60 days after admission. Both clinical and some social data were collected at these time points. Clinical chemistry and biochemistry tests were conducted on samples collected in all the visits as well as blood culture and stool culture were also collected on some visits. All serious adverse events and toxicity events were recorded as well and were investigated and their data has been included here as well. Also included in the package is the Statistical Analysis Plan (SAP) for the trial, blank copies of the study questionnaires, informed consent form and data dictionary Trial Registration: www.clinicaltrials.gov NCT04542473本数据集包含参与PBSAM试验的429名受试者的临床信息（详细内容参见试验方案）。受试者需满足以下纳入标准方可入组：至少具备2项急性疾病重症特征，且确诊重度急性营养不良。受试者出院后将被随访6个月。 数据采集节点包括：入院时、住院期间每日查房、出院时、入院后21天，以及入院后60天。上述所有访视节点均采集临床及部分社会数据。所有访视均采集样本进行临床化学与生物化学检测；部分访视还额外采集了血液培养及粪便培养样本。所有严重不良事件与毒性事件均已完成记录与调查，相关数据亦收录于本数据集。 本数据包还包含该试验的统计分析计划（Statistical Analysis Plan, SAP）、研究问卷空白副本、知情同意书以及数据字典。试验注册信息：www.clinicaltrials.gov NCT04542473