Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months: a Double-blind, Randomized, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.
详细描述
Probiotics are live bacteria that offer a health benefit to the host when administered via the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the elderly and has demonstrated beneficial effects for a wide variety of health conditions such as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease. The immune-enhancing benefits of probiotics are attractive, particularly for infants, a group that is particularly prone to a variety of infections, e.g. respiratory tract infection, strep throat, and diarrhea. Probiotic supplementation has been utilized in previous studies of childhood infections with promising results.
In this study, the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months will be determined. The subjects will receive follow-on formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 to 12 months.
- •Known vaccination history.
- •Ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects.
- •Parental or legal guardian's consent to the study and willing to comply with study procedures.
排除标准
- •Symptoms of any infection at screening.
- •History of ≥5 infections in the previous 2 months.
- •Lactose intolerance or unable to drink milk.
- •Leukopenia or leukocytosis.
- •Immunodeficient or use of immunosuppressive drugs.
- •Use of antibiotic and anti-inflammatory medications within the last 2 weeks.
- •Use of products containing prebiotics or probiotics within the last 2 weeks.
- •Use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks.
- •Hepatitis B or C.
- •Medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator.
- •Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
- •Participation in another study with any investigational product within 3 months of screening.
- •Any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial.
结局指标
主要结局
The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
时间窗: 12 weeks
The primary endpoint of this clinical trial is the proportion of subjects with one or more of the following confirmed bacterial or viral infections at any time during the study: fever \> 37.5ºC (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.
次要结局
- Cumulative days with infectious symptoms(12 weeks)
- Cumulative number of infectious episodes(12 weeks)
- Infant Characteristics Questionnaire(12 weeks)
- Treatments for infectious episodes(12 weeks)
- Adverse events(12 weeks)
- Stool frequency(12 weeks)
- Stool Consistency(12 weeks)