A Multicentre, Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilis HU58 + Bacillus coagulans SC208 Syrup in Treatment of Acute Diarrhoea in Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- 1.Stool consistency (as assessed by Bristol Stool Scale (BSS)[ including 7 types as follows: type 1 to 2 indicates constipation; type 3 to 5 suggests normal stools; and type 6 to 7 means liquid stool]
研究概览
简要总结
The overall study will be conducted in subjects with acute diarrhoea. A (-1) day screening period and a treatment period of 7 Days. The duration of individual participation will be approximately 7 days. Eligible patients will be randomized in two arms.The subjects would be assigned to Arm A(test group) or Arm B(placebo) in the ratio of 1:1 (16:16 subjects per Arm) for both the cohorts.
For both the cohorts subjects will be assessed for the safety and efficacy from baseline to the end of study visit
The primary outcome evaluates Stool consistency as assessed by Bristol Stool Scale (BSS) and duration of diarrhoea in days.
A secondary outcome evaluates abdominal pain intensity as assessed by the visual analogue scale from baseline to end of study.
Safety will be assessed on the frequency of Adverse Events and changes in laboratory values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female subjects between ≥1 to ≤ 12years of age both inclusive.
- •The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child will comply with the requirements of the protocol.
- •Written informed consent /assent obtained from the parent(s)/LAR(s) of the subject and the subject respectively for participation in the study.
- •Cohort 1:
- •Subjects undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.
- •Subject suffering from Antibiotic-associated Diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period.
- •Cohort 2:
- •Subject with clinical diagnosis of acute infective diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period and lasting for less than three days).
排除标准
- •History of pre-existing diarrhoea within the previous 4 weeks.
- •Subjects requiring hospitalisation.
- •Subjects with Severe dehydrationrequiring intravenous rehydration.
- •Subjects with bloody and/or purulent stools
- •Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn‘s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhoea and functional constipation.
- •Subjects with gastrointestinal surgery.
- •History of severe chronic systemic diseases, critical/life-threatening illness or immunodeficiency diseases.
- •Known hypersensitivity to any of the ingredients in the probiotic product or the placebo.
- •Use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic 14 days before and during the study
- •Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study.
- •Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
结局指标
主要结局
1.Stool consistency (as assessed by Bristol Stool Scale (BSS)[ including 7 types as follows: type 1 to 2 indicates constipation; type 3 to 5 suggests normal stools; and type 6 to 7 means liquid stool]
时间窗: 7 Days
2.Duration of diarrhoea in days (time between the start of treatment until last diarrheal/watery stool before recovery or end of study treatment).
时间窗: 7 Days
次要结局
- Abdominal pain intensity [as measured by visual analogue scale (VAS)].(7 Days)
- The assessment of safety of Investigational Product will be based on the frequency of Adverse Events and changes in laboratory values. All safety variables will be summarized using descriptive statistics(7 Days)