Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 主要终点
- Change from baseline Innate immunity at 30 days of life and at 90 days of life.
研究概览
简要总结
This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group.
The aim of the study was to investigate the immunity of infant born from caesarian section and fed with formula milk containing fermented matrix a double and triple dosage compare the first part of the trial FERCT15 assuming a dose-effect relationship of the fermented matrix with immune response.
详细描述
The microbiota plays an important role in modulating the development of the immune system, making decisive the interrelation that between nutrition, microbiota and immune cells to modulate long-term health outcomes.
The type of feeding, especially breastfeeding, and the type of delivery are factors that can contribute to the development of the microbiota. Specifically, the exclusive breastfeeding promotes the development of bifidobacteria that promotes protection against potential infections and the development of the immune system.
In recent years it was improved the biological effects of formula milk, that represent the substitutes of breast milk when this is not available or if there are contraindications to breastfeeding. Functional foods derived from fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases of the child. Recently, in a monocentric double-blind prospective study, the efficacy of fermented cow's milk with Lactobacillus paracasei CBA L74 was evaluated in the prevention of common winter infections in children aged between 12 and 48 months. In this study, children treated with fermented milk had a lower incidence of respiratory and gastrointestinal tract infections compared to the control group. This effect was associated with a significant stimulation of innate immunity (α- and β-defensin, LL-37) and acquired (secretory IgA) and to a modulation of composition and function of the intestinal microbiota characterized by a significant increase in strains producing butyric acid (Firmicutes phyla). The nutritional intervention was very well accepted by the children and no adverse events were observed.
From previous results emerged that in infants born by eutocic delivery fed with fermented formula milk, there is more valid response of innate and acquired immunity compare to controls. In infants born by cesarean section this response is less expressed. It is possible to suppose that this response is linked to a different microbiota.
Primary objectives of this study were:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term healthy infants
- •Gestational age from 37 to 41 weeks
- •Weight appropriate for gestational age (from 10th to 90th centile according to World Health Organization chart)
- •Human milk not available or not possible
排除标准
- •Weight small for gestational age (< 10th centile) or large for gestational age (> 90th centile) according to World Health Organization chart
- •Congenital abnormalities, chromosomal, hearth, gastrointestinal, respiratory, neurological or metabolic disease.
- •Perinatal infections
- •Positive familiarity for milk proteins allergies
结局指标
主要结局
Change from baseline Innate immunity at 30 days of life and at 90 days of life.
时间窗: 0-7 days of life, at 30 days of life and at 90 days of life.
Fecal dosage of catelecidines, alfa and beta defensins and sIgA
次要结局
- Anthropometry(0-7 days of life, at 30 days of life and at 90 days of life.)
- Body composition(Time Frame: 0-7 days of life and at 90 days of life.)
- Gastrointestinal tolerance(0-7 days of life, at 30 days of life and at 90 days of life)
- Microbiota(0-7 days of life and at 90 days of life.)
- Weight(0-7 days of life, at 30 days of life and at 90 days of life.)
- Metabolomics(0-7 days of life and at 90 days of life.)