Szymański Henryk, Szajewska Hania
Department of Pediatrics, St Hedwig of Silesia Hospital, Trzebnica, Poland.
Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland.
JMIR Res Protoc. 2017 Aug 23;6(8):e164. doi: 10.2196/resprot.7924.
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. However, despite proven efficacy, it remains underused. This is because oral rehydration solution neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness. Hence, there is interest in adjunctive treatments. According to the 2014 guidelines developed by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, the use of the following probiotics may be considered in the management of children with AGE in addition to rehydration therapy: Lactobacillus rhamnosus GG (low quality of evidence; strong recommendation) and Saccharomyces boulardii (low quality of evidence; strong recommendation). Less compelling evidence is available for Lactobacillus reuteri DSM 17938 (very low quality of evidence; weak recommendation).
Considering that evidence on L reuteri remains limited, the goal of the study is to assess the effectiveness of L reuteri DSM 17938 in the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.
This will be a double-blind, placebo-controlled, randomized trial. Children between 1 and 60 months of age with AGE, defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form scale or Amsterdam Stool Form scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h) lasting for no longer than 5 days, will be recruited. A total of 72 children will receive either L reuteri DSM 17938 at a dose of 2×10colony-forming units twice daily or matching placebo for 5 consecutive days. A similar sample size for rotavirus vaccinated and nonvaccinated children is planned. The primary outcome measure is the duration of diarrhea. Two separate studies and reports for rotavirus vaccinated and nonvaccinated children are planned.
The recruitment started in January 2017 and is planned to be finalized in June 2018 for rotavirus nonvaccinated children. The recruitment of rotavirus-vaccinated children may be slower due to a relatively low coverage rate in Poland. Data analysis and submission to a peer-reviewed journal is expected within 3 months after completion of the study.
This study will add to current knowledge on the efficacy of L reuteri DSM 17938 for the management of AGE.
ClinicalTrials.gov NCT02989350; https://clinicaltrials.gov/ct2/show/NCT02989350 (Archived by WebCite at http://www.webcitation.org/6slOFkyTH).
急性肠胃炎（AGE）是儿童中最常见的疾病之一。口服补液疗法是关键治疗方法。然而，尽管已证实其疗效，但仍未得到充分利用。这是因为口服补液溶液既不能减少排便次数和体液流失，也不能缩短疾病持续时间。因此，人们对辅助治疗感兴趣。根据欧洲儿科胃肠病学、肝病学和营养学会2014年制定的指南，除补液疗法外，在AGE儿童的管理中可考虑使用以下益生菌：鼠李糖乳杆菌GG（证据质量低；强烈推荐）和布拉酵母菌（证据质量低；强烈推荐）。关于罗伊氏乳杆菌DSM 17938的证据说服力较弱（证据质量极低；弱推荐）。
鉴于关于罗伊氏乳杆菌的证据仍然有限，本研究的目的是评估罗伊氏乳杆菌DSM 17938治疗儿童AGE的有效性。将分别评估接种和未接种轮状病毒疫苗的儿童。
这将是一项双盲、安慰剂对照的随机试验。招募1至60个月大的患有AGE的儿童，AGE定义为粪便质地变为松散或液体状（根据布里斯托大便分类法或阿姆斯特丹大便分类法）和/或排便频率增加（通常24小时内≥3次），持续时间不超过5天。总共72名儿童将连续5天每天两次接受剂量为2×10菌落形成单位的罗伊氏乳杆菌DSM 17938或匹配的安慰剂。计划对接种和未接种轮状病毒疫苗的儿童采用相似的样本量。主要结局指标是腹泻持续时间。计划针对接种和未接种轮状病毒疫苗的儿童进行两项独立的研究和报告。
招募工作于2017年1月开始，计划于2018年6月完成未接种轮状病毒疫苗儿童的招募。由于波兰的覆盖率相对较低，接种轮状病毒疫苗儿童的招募可能会较慢。预计在研究完成后3个月内进行数据分析并提交给同行评审期刊。
本研究将增加关于罗伊氏乳杆菌DSM 17938治疗AGE疗效的现有知识。
ClinicalTrials.gov NCT02989350；https://clinicaltrials.gov/ct2/show/NCT02989350（由WebCite存档于http://www.webcitation.org/6slOFkyTH）。
