The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, Warsaw, Poland.
The Department of Pediatrics with Clinical Assessment Unit, Medical University of Warsaw, Warsaw, Poland
BMJ Open. 2021 Mar 11;11(3):e042370. doi: 10.1136/bmjopen-2020-042370.
Acute gastroenteritis is one of the most common causes of children's morbidity and mortality globally. Oral or intravenous rehydration was proven effective in reducing the mortality rates in acute gastroenteritis, although it does not affect the course of the disease. Attempts to identify new therapeutic methods effective in reducing the symptoms of diarrhoea are of interest. Pleuran's potential immunomodulatory effect in acute gastrointestinal infection relies on the stimulation of innate immunity. The effectiveness of pleuran (β-(1,3/1,6)-d-glucan) administration to treat acute infectious diarrhoea remains unknown. This study evaluates the efficacy of pleuran in reducing diarrhoea duration and the severity of acute gastroenteritis symptoms in children.
Our study is a randomised, double-blind, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio. A total of 120 children aged 2-10 years hospitalised or requiring a visit to the emergency department because of acute gastroenteritis will be randomly assigned to receive either pleuran oral suspension in the experimental group or matching placebo in the control group. The primary outcome measure will be the duration of diarrhoea. We will analyse the results in both intention-to-treat and per-protocol approaches.
The Bioethics Committee of The Medical University of Warsaw approved the study protocol (approval number: KB/45/2018). Written informed consent of the patients' caregivers participating in the study will be obligatory. The results of this study will be published in a medical journal, regardless of whether they confirm or deny the research hypothesis.
NCT03988257; Pre-results.
急性肠胃炎是全球范围内导致儿童发病率和死亡率的最常见原因之一。口服或静脉补液已被证明可有效降低急性肠胃炎的死亡率，尽管它不会影响疾病的进程。寻找新的治疗方法以有效减轻腹泻症状的尝试具有重要意义。Pleuran 在急性胃肠道感染中的潜在免疫调节作用依赖于对先天免疫的刺激。Pleuran（β-（1,3/1,6）-d-葡聚糖）治疗急性感染性腹泻的有效性尚不清楚。本研究评估了 Pleuran 缩短儿童急性感染性腹泻病程和减轻急性肠胃炎症状严重程度的疗效。
我们的研究是一项随机、双盲、安慰剂对照的优效性试验，分为两组，比例为 1:1。共有 120 名 2-10 岁的儿童因急性肠胃炎住院或需要到急诊就诊，他们将被随机分配到实验组接受 Pleuran 口服混悬液或对照组接受匹配的安慰剂治疗。主要结局指标是腹泻持续时间。我们将在意向治疗和方案治疗的基础上分析结果。
华沙医科大学伦理委员会批准了该研究方案（批准号：KB/45/2018）。参与研究的患者监护人必须签署书面知情同意书。无论研究结果是否证实或否定研究假设，本研究结果都将在医学期刊上发表。
NCT03988257；预结果。
