A cross-sectional study to assess the real world utilization and safety of Multistrain probiotic in Acute gastroenteritis in outpatient settings of India (MAESTRO Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,905
- 试验地点
- 1
- 主要终点
- Changes in stool frequency and consistency after probiotic administration.
研究概览
简要总结
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Aim of this study is to assess the real world utilization and safety of multistrain probiotic in acute gastroenteritis in outpatient settings of India.
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- Study design: A Real World, Cross-sectional Study
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- Duration of study: 6 months
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Duration of observation: 1 week
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- Product Strength
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Srteptococcus faecalis 30 million Clostridium butyricum 2 million Bacillus mesentricus 1 million Lactobacillus Sporogenes 50 million Saccharomyces boulardii 50 million
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- Dosage Form Oral solid
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- Dosage As directed by the physician
- Route of Administration: Oral
As the study will be conducted in the real life setting, study medication will be prescribed by the
investigator and the patients will purchase the drug from the pharmacy. Compliance will be
assessed from the case record sheets. Source data will be assessed for compliance and captured
appropriately and regularly monitored by the sponsor for classification as treatment completers.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with acute gastroenteritis and treated with multistrain probiotics for 7 days.
排除标准
- •Contraindications to ingredients.
- •Any other condition or factors as per discretion of treating physician.
结局指标
主要结局
Changes in stool frequency and consistency after probiotic administration.
时间窗: From baseline (Day-0) to Day-7
次要结局
- Most common cause of acute gastroenteritis.(Change in ORS requirement.)
研究者
Dr Bhavna Patel
Medicure Hospital