A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of Bacillus coagulans MTCC 5856 in management of acute diarrhea in children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- a)Mean duration of diarrhea (expressed in hours), as counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score a score 5 is described as normalization of stool)
研究概览
简要总结
At screening visit, demographics, vital signs, physical examination, medical and medication history will be done to assess the eligibility criteria by the Pediatrician.
The eligibility criteria will be verified. If the subject is found eligible, he/she will be randomized, and Investigational product will be dispensed to the parents or legal guardian to administer orally twice daily to the children. Stool sample will be collected for rotavirus and adenovirus screening. Children will be under observation of study team for six hours post 1st dose. Parents will be given subject diary and will be instructed to record diarrhea frequency and duration of diarrhea as well as investigational product compliance on daily basis. Information regarding the reporting of adverse events will be provided to the parents and will be instructed to visit site on day 3 and day 5. On day 3 and 5, vitals, physical examination, concomitant medication will be recorded. Duration and frequency of the diarrhea will be recorded in diary for all 5 days. Bristol stool chart will be assessed for all the episodes for all 5 days in a diary. Perceived efficacy scale of caregivers will be assessed on day 3 and day 5. Investigational product accountability will be done on day 5. The subject diary will be collected on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 1 to 10 years diagnosed with acute diarrhea.
- •2.Children who experienced more than 3 watery stools within last 24 hours.
- •3.Signed informed consent from one of the parents/legal guardians.
- •4.Children aged above 7 years willing to provide verbal assent will be counter signed by Parents.
- •5.Parents’/legal guardians’ willing to comply with all its procedures.
排除标准
- •1.Subjects who require antibiotics treatment.
- •2.Subject who require intravenous fluid therapy.
- •3.Severe diarrhea which requires treatment other than ORS.
- •4.Severe dehydration as per WHO dehydration scale.
- •5.Immunodeficiency.
- •6.Malnourished (weight for height < 3 SD of WHO charts).
- •7.Surgery within one month prior to inclusion.
- •8.Children suffering from severe chronic illness.
- •9.Chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies).
- •10.No consumption of commercial products containing probiotics including Yakult, during the study period.
- •11.Participation in any other clinical trial within 4 weeks prior to entry into the study.
- •12.Children Hospitalized for Pneumonia and acute gastroenteritis.
- •13.Children having bilious vomiting, hematochezia, pancreatic dysfunction or insufficiency judged by medical history.
结局指标
主要结局
a)Mean duration of diarrhea (expressed in hours), as counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score a score 5 is described as normalization of stool)
时间窗: 1 Day 3 & Day 5 | 2 Day 3 & Day 5
b)Mean diarrhea frequency per day after initiation of treatment
时间窗: 1 Day 3 & Day 5 | 2 Day 3 & Day 5
次要结局
- a)Perceived efficacy among caregivers per perceived efficacy scale.(b)Dehydration status evaluated as per WHO classification.)