A double blind, placebo-controlled, randomized, parallel-group study to evaluate the efficacy of probiotic formulation in amelioration of antibiotic associated diarrhoea in children.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in the incidence of antibiotic-associated diarrhoea assessed in the investigational product arm compared to placebo.
研究概览
简要总结
This is a double blind, randomized, placebo controlled, two-arms, parallel group study. 300 infants or children meeting all eligibility criteria would be screened in the study after obtaining written informed consent from parents or guardians. The eligible subjects will be randomized into one of the 2 treatment arms to receive either the treatment arm or placebo twice a day. Probiotic or Placebo suspension will be continued for one week after cessation of antibiotic treatment. Clinical assessments will be performed as per the protocol. Details of antibiotic associated diarrhoea will be assessed using questionnaires. A diary will be provided to record the study IP administration, details of diarrhoea, side effects, hospital stay, rescue medication, and concomitant medication details during the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Outpatients with a proven or suspected infection anticipated to be treated on physicians prescribed amoxicillin+ clavulanate or other combinations with amoxicillin.Willing to give written informed consent/assent.
排除标准
- •1.Subject with history of o Prior use of antibiotics within the previous 6 weeks.
- •o Presence of a severe or generalised infection.
- •o Severe chronic disease.
- •o Pre-existing diarrhoea within the previous 4 weeks.
- •2.Patients with bloody or purulent stool, with pus or mucus.
- •3.Severe dehydration needing hospitalization.
- •4.Infants on exclusive breastfeeding 5.Requiring hospitalization 6.An axillary temperature greater than 38.2°C or an oral temperature greter than 38.6°C.
- •7.Symptoms of septicaemia 8.Subjects having hypersensitivity or history of allergy to any component of the study product.
- •Unable to take medication orally or tolerate oral rehydration.
- •10.Taken probiotics prior to study (2 months) or during study other than interventional product.
- •11.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.
- •12.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations or any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.
- •13.History of intubations for co-morbidities like, chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.
- •14.Use of any other investigational drug currently or within 30 days prior to study entry.
- •15.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •16.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Change in the incidence of antibiotic-associated diarrhoea assessed in the investigational product arm compared to placebo.
时间窗: Day 1, Day 7, Day 15 and Day 30
次要结局
- Change in the efficacy parameters assessed in the investigational product arm compared to placebo at a defined time points in comparison to baseline(Day 1, Day 7, Day 15 and Day 30)
- Fecal microbiota analysis(Day 1 and Day 30)
研究者
Dr Rohith H R
BGS Global Institute of Medical Sciences