Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Duration of diarrhea
研究概览
简要总结
Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.
Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days.
- •Age: older than 1 month and younger than 60 months.
- •A caregiver must provide written informed consent.
排除标准
- •Use of antibiotics within two weeks prior to enrolment.
- •Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed).
- •Breast feeding (>50%)
- •Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy)
- •Immunodeficiency
- •Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
研究组 & 干预措施
Lactobacillus reuteri DSM 17938
2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days.
干预措施: Lactobacillus reuteri DSM 17938 (Dietary Supplement)
Placebo
Placebo consists of an identical formulation, except active substance.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Duration of diarrhea
时间窗: 8 days
(measured in hours) - time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) - (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h.
次要结局
- Need for hospitalisation of outpatients(8 days)
- Use of concomitant medications(8 days)
- Severity of diarrhoea according to Vesikari scale(8 days)
- Vomiting(8 days)
- Recurrence of diarrhoea (in 48 hours after intervention)(48 hours)
- Need for intravenous rehydration(8 days)
- Duration of intravenous rehydration(8 days)
- Number of watery stools per day(8 days)
- Adverse events(8 days)
研究者
Henryk Szymański
MD PhD
Szpital im. Św. Jadwigi Śląskiej