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临床试验/NCT01454661
NCT01454661Unknown不适用

Probiotic Modulation of Early Microbial Contact in Premature Infants

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Gut microbiota

研究概览

简要总结

Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown.

This research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial.

The specific aims of the project are:

  1. To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured.
  2. To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed.
  3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • premature infant born at <35 weeks gestational age

排除标准

  • severe asphyxia
  • significant anomalies

研究组 & 干预措施

placebo mother - LGG infant

Active Comparator

Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.

干预措施: LGG (Dietary Supplement)

placebo mother - placebo infant

Placebo Comparator

Placebo is administered to both the lactating mother and her infant.

干预措施: Placebo (Dietary Supplement)

LGG mother - placebo infant

Active Comparator

The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.

干预措施: LGG (Dietary Supplement)

LGG+Bb-12 mother - Placebo infant

Active Comparator

A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.

干预措施: LGG+Bb-12 (Dietary Supplement)

Pacebo mother - LGG+Bb-12 infant

Active Comparator

Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12

干预措施: LGG+Bb-12 (Dietary Supplement)

结局指标

主要结局

Gut microbiota

时间窗: 1 month

Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life

次要结局

  • Breast milk compostion(1 months)
  • Intestinal immunity(1 month)

研究者

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

Samuli Rautava

Principal Investigator

Turku University Hospital

研究点 (2)

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