CTRI/2020/03/023936已完成3 期
A Prospective, interventional, randomized, double blind, parallel, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii 088AE in the Treatment of Antibiotic-Associated Diarrhoea.
Advanced Enzyme Technologies Ltd2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1.Time to Last Unformed Stool (TTLUS) – At 24 h, 72 h, 120 h, 168 h & End.
研究概览
简要总结
A Prospective, Interventional, Randomized, Double blind, Parallel, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii 088AE in the Treatment of Antibiotic-Associated Diarrhoea.
Total 120 subjects
| 1. Placebo Pediatric AAD (n=30 randomized) [Pediatric; Age group: 2-10 Years] 2. Test Pediatric AAD (n=30 randomized) [Pediatric; Age group: 2-10 Years] 3. Placebo adolescent & Adult AAD (n=30 randomized) [Adolescent & adult; Age group: 11-up to 65 Years] 4. Test adolescent & Adult AAD (n=30 randomized) [Adolescent & adult; Age group: 11-up to 65 Years] |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and females aged >2 and <65 years completed years (both inclusive) with symptoms of antibiotic treatment induced diarrhea manifesting within at least 48 hours or more than prior to entering the trial 2.Patients having experienced at least three incidences of unformed stool (Type 7 by Bristol Stool form scale) within at least 48 hours or more than prior to entering the trial 3.Patients with diarrhea induced due to ongoing antibiotic therapy (Patients should be on the initial 4 days of antibiotic therapy which is given for at least for 14 days 4.Patient must have complaints of related gastrointestinal disorders caused by various abdominal discomforts within the last hour 5.Willing to give written informed consent or assent form by study participants or parent wherever applicable.
排除标准
- •1.Patients with bloody or purulent stool, with pus or mucus.
- •2.Severe dehydration needing hospitalization.
- •3.An axillary temperature greater than (>) 38.2°C or an oral temperature > 38.6°C 4.Symptoms of septicemia (Fever, shivering, or feeling cold, fast heart rate, fast breathing and shortness of breath, sweaty or clammy skin, etc.) 5.Unable to take medication orally or tolerate oral rehydration.
- •6.Taken probiotics prior to study (2 weeks) or during study other than interventional product.
- •7.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.
- •9.Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.
- •10.History of intubations for co-morbidities (chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.
- •11.Use of any investigational drug currently or within 30 days prior to study entry.
结局指标
主要结局
1.Time to Last Unformed Stool (TTLUS) – At 24 h, 72 h, 120 h, 168 h & End.
时间窗: screening to end of treatment
2.Number of unformed stools at time points - At 24 h, 72 h, 120 h, 168 h & End – starting from first IP administration.
时间窗: screening to end of treatment
4.% responders as defined by the number of subjects with complete remission of diarrhea within 24 h, 72 h, 120 h, 168 h & End
时间窗: screening to end of treatment
3.Time to complete resolution of functional gastrointestinal discomforts- At 24 h, 72 h, 120 h, 168 h & End
时间窗: screening to end of treatment
次要结局
- 1.To evaluate the changes of the severity of AAD related symptoms(2.To evaluate the changes in VAS score of AAD at 24 h, 72 h, 120 h, 168 h & End)
研究者
研究点 (2)
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