A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Assess the Safety and Effectiveness of a Probiotic Nutraceutical Product in Subjects with Diarrhea and Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel group clinical interventional study. The subjects will be explained about the study procedures, the risks and discomforts, the investigational product (IP). Informed consent will be obtained from subjects who are willing to participate in the study. The subjects who fulfil the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. The subjects will be randomized into one of the treatment arms (1:1) as per randomization schedule. The subject will be instructed to consume the IP or placebo, orally, once a day, 30 minutes before meal for 1 week. The subjects will be required to come for the follow-up assessments on Day 3, and Day 7. Statistical comparisons for efficacy shall be made between test product and placebo. The total study duration for the clinical part shall be a maximum of 7+1 days of treatment period.
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
- 19.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with acute diarrhoea having more than 3 loose stools in last 24 hours
- •Subjects with diarrhoea less than 7 days
- •Subjects who agrees to participate in this trial and signs a written consent form before the test begins.
排除标准
- •Subjects with mucous stools or bleeding per rectum
- •Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors, etc
- •Subjects with a history of gastrointestinal surgery
- •Subjects with a history of malignant tumor of the digestive system
- •Subjects who have within 2 weeks of Visit 1, have taken probiotics, anti-diarrhoeal medication, H2 receptor blockers, anticholinergics, gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosa protectors, other drugs for the treatment of gastritis, and health functional foods related to gastrointestinal health
- •Subjects who must continuously take drugs that can cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin, during the human application test period however, low dose aspirin 100 mg per day or less is allowed for the purpose of preventing cardiovascular disease
- •Subjects with uncontrolled high blood pressure
- •Subjects who are sensitive or allergic to the food ingredients for this human application test
- •Subjects refusing to stop eating foods and functional foods that may affect digestive system symptoms
- •Subjects who are pregnant, lactating, or planning to become pregnant within 3 months.
- •Subjects who have participated in other interventional clinical trials within 3 months of visit 1, or who plan to participate in other interventional clinical trials after the start of this human trial.
- •Subjects judged by the tester to be inappropriate for this human application test.
研究者
Dr Shashank S Gowda
BGS Global Institute of Medical Sciences