跳至主要内容
临床试验/NCT00894816
NCT00894816已完成不适用

Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health

Umeå University1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2000年8月1日最近更新:
适应症
干预措施

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

Active Comparator

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 Comparator

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina West

Dr

Umeå University

研究点 (1)

Loading locations...

相似试验

Probiotics in Prevention of Allergies, Obesity and... | 临床试验