Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Eczema
研究概览
简要总结
During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. The effects of LF19 on gut microbial composition, infections, allergies, immunological development, growth and blood lipids were monitored. Of 179 included infants, 171 completed the study. The study product was well tolerated with no observed side effects. Compliance was excellent.
In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during weaning on allergies, immune programming, overweight, gut microbial composition and oral health in 8-year old children.
The investigators' primary outcome will be to determine whether daily intake of LF19 during weaning results in less eczema at 8 years of age, and if the preventive effect encompasses also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects on gut microbial composition, overweight and metabolic markers will be investigated. Furthermore, the possible preventive effects of LF19 on caries will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 4 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants born at term (gestational age 37-42 weeks)
- •Birth weight > 2500 g
- •Vaginally delivered
- •No atopic manifestation
- •A normal diet for age
- •No medication that could have affected the intestinal microbiota
排除标准
- 未提供
研究组 & 干预措施
1
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving
干预措施: Lactobacillus F19 (Dietary Supplement)
2
Placebo (infant cereals without any additions)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Eczema
时间窗: 8 years of age
Eczema including related allergic manifestations
次要结局
- Respiratory allergies(8 years of age)
- Sensitization(8 years of age)
- Overweight/obesity(8 years of age)
- Gut microbial composition(8 years of age)
- Caries(8 years of age)
