A prospective, randomized, multicenter, parallel-group clinical study evaluating the efficacy and safety of Sporlac in the management of acute diarrhea.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Stool frequency over treatment duration in the two groups.
研究概览
简要总结
In this study, pediatric patients aged 6 months to 18 years diagnosed with acute diarrhea, characterized by the sudden onset of more than 3 loose or watery stools within 24 hours, will be screened and enrolled if found eligible at Assessment 1 (Initiation of treatment – Day 0). All enrolled patients will undergo an in-person follow-up at Assessment 2 (End of the treatment - Day 5). A total of 300 pediatric patients with acute diarrhea in India will be enrolled in this clinical trial to evaluate the efficacy and safety of Sporlac in management of acute diarrhea. This is a two arm study, with subjects randomized to receive either Test treatment (Sporlac + SOC) or Reference treatment (SOC). Primary objective of study is to evaluate the efficacy of Sporlac in the management of acute diarrhea. Secondary objective is to assess the safety of Sporlac in the management of acute diarrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Pediatric male and female patients aged 6 months to 18 years.
- •Patients diagnosed with acute diarrhea, characterized by the sudden onset of more than 3 loose or watery stools within 24 hours.
- •Parent of patient willing to provide written informed consent for their children.
- •Parent of patient (or their legal guardians, where applicable) willing to complete subject diaries and respond to study questionnaires, including daily documentation of stool frequency, stool consistency, and other efficacy parameters in diary card or willing to document all the details telephonically to CRC on daily basis.
- •Parent of patient with access to a functioning telephone for study-related communication.
- •Patients in generally good health, with no known significant underlying medical conditions that could interfere with study outcomes.
排除标准
- •Known hypersensitivity to Sporlac Powder/ DS Tablet or any component of the formulation.
- •Severe dehydration requiring hospitalization or any patient with symptoms of dehydration needing inpatient care at the time of study enrolment.
- •Patients currently on medications that may interact with Sporlac or those on concurrent medications that could interfere with the study outcomes or standard treatment for diarrhea.
- •Recent use of non-prescribed probiotic supplements or anti-diarrheal (including products containing live cultures, such as yogurt) or antibiotics within the last seven days for the treatment of diarrhea.
- •Patients with known significant uncontrolled medical conditions, including chronic gastrointestinal disorders (except irritable bowel disease) or other systemic diseases.
- •Current presence of blood, pus, or mucus in stools, or a history of these symptoms within the previous 3 months.
- •Persistent diarrhea, defined as a duration exceeding 14 days.
- •Severe or persistent vomiting that may interfere with study participation or outcomes.
- •Participation in another clinical trial within the last 30 days.
- •Pregnant or breastfeeding women, or women of childbearing potential
- •Not willing to comply with the study requirements.
结局指标
主要结局
Stool frequency over treatment duration in the two groups.
时间窗: At the end of treatment (Day 5)
次要结局
- Stool consistency using Bristol stool scale over treatment duration in the two groups.(At the end of treatment (Day 5))
- Time to first formed stool after initiation of treatment(Baseline Vs End if Treatment (Day 5))
- Abdominal pain score using NRS (more than 8 years) or over treatment duration in the two(groups.)
- Presence or absence of other associated abdominal symptoms during treatment period(Baseline Vs End of Treatment (Day 5))
- Adverse events reported during the study(At the End of Study (Day 5))
- Serious adverse events reported during the study(At the End of Study (Day 5))
研究者
Dr Jayesh Sanmukhani
Clinexcel Research