Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
研究概览
简要总结
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
详细描述
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Every product will be provided in identical packaging
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants
- •Age between 1 and 90 days
- •Gestational age between 37 and 42 weeks
- •Appropiate birth weight for gestational age (between P10 and P90)
- •APGAR test score for birth normal at 1' and 5' of 7-10
- •Whose parents accept the follow-up of the study procedures and sign the informed consent
排除标准
- •Infants participating in other clinical study
- •Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
- •Infants who have taken antibiotics 4 weeks prior the start study
- •Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
- •Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
- •Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
- •TORCH complex infections
- •Every other diseases related with the immune system
- •Parents who can not accomplish the follow-up of the study (medical criterium)
结局指标
主要结局
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces
时间窗: day 0, month 3
Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR
次要结局
- Weight change(day 0, month 1, month 2, month 3)
- Length change(day 0, month 1, month 2, month 3)
- Head circumference change(day 0, month 1, month 2, month 3)
- BMI change(day 0, month 1, month 2, month 3)
- Frequency of depositions(day 0, month 1, month 2, month 3)
- Consistency of stools(day 0, month 1, month 2, month 3)
- Infant colic(day 0, month 1, month 2, month 3)
- Incidence of infections(day 0, month 1, month 2, month 3)
- Vomiting(day 0, month 1, month 2, month 3)
- Fever(day 0, month 1, month 2, month 3)
- Antibiotics(day 0, month 1, month 2, month 3)
- Change in fecal microbiota composition(day 0, month 3)
- sIgA in stool samples(day 0, month 3)
- Calprotectin(day 0, month 3)
- Sleeping habits(day 0, month 1, month 2, month 3)