A Prospective, Double-Blind, Three-Arm, Placebo-Controlled, single-Centre, Comparative Clinical Study to Evaluate the Safety Profile of Probiotic Mixture A (2 Strains) and Probiotic Mixture B (2 Strains) in Healthy Children.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
研究概览
简要总结
This is a prospective, randomized, double-blind, placebo-controlled, Single-centre clinical study designed to evaluate and compare the safety and tolerability of two high-dose, multi-strain probiotic mixtures in healthy children aged 2 to 8 years. The study will assess Probiotic Mixture A and Probiotic Mixture B, each containing two well-known lactic acid bacteria strains, administered at a daily dose of 200 billion CFU, against a placebo. Safety will be evaluated over a 90-day period through monitoring of adverse events, laboratory parameters, vital signs, and parent-reported tolerability. The study aims to generate robust clinical safety data to support the safe use of probiotic formulations in pediatric populations.
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
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children aged 2 to 8 years -Assessed as healthy based on medical history physical examination vital signs and laboratory tests -Parent or legal guardian able to provide written informed consent before any study procedures -Parent or legal guardian willing to follow the study protocol -Parent or legal guardian agrees to maintain a participant diary and report any adverse events during the study.
排除标准
- •Participation in any other clinical trial or use of an investigational product within 90 days prior to screening -Known allergy or hypersensitivity to any component of the study product or placebo -History or presence of any significant medical condition including gastrointestinal hepatic renal metabolic cardiovascular neurological or immunological disorders that may affect study participation or safety -History of psychiatric illness -Acute illness infection or fever at the time of screening -Abnormal laboratory values at screening considered clinically significant by the Investigator -Use of antibiotics probiotics prebiotics or synbiotics within 14 days prior to screening -Children receiving long term medication that may interfere with study outcomes -Any other condition or circumstance that in the opinion of the Investigator makes the child unsuitable for the study.
研究者
Dr Sharmili Ugraiah
Currex Hospital