Nutrition, Allergy, Mucosal Immunology and Intestinal Microbiota (NAMI): Pre-, Peri- and Postnatal Programming and Origins of Disease: Early Targeting the Epidemics of Allergy and Overweight
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Number of participants with allergic disease
研究概览
简要总结
Combined programme: Nutrition, Allergy, Mucosal immunology and Intestinal microbiota (NAMI) was created with the objective to reverse the rising trend of chronic inflammatory diseases, such as allergic disease and obesity, by control of the internal and external environments of the infant. To approach this problem, the project aims to characterize
- how immunology is regulated during pregnancy and early infancy,
- how the immune interaction between mother and child is influenced by nutritional and microbial factors, and
- how the regulation is related to disease risk.
详细描述
While allergic diseases comprise the most common chronic disease in childhood, obesity is the most prevalent nutritional disorder among children throughout the world. In Europe, an estimated 20% of children and adolescents are overweight with one-third of these being considered obese. Moreover, escalation of these problems is expected in the future, since the velocity of propagation is highest in children. Although genetic factors can determine the propensity of an individual to become allergic or obese, these unlikely explain the recent and progressive worldwide increases in incidence. Rather, it would appear that the environmental changes more directly shape the risk during a critical period of life when the scene is set for the consolidation of the immune responder type. Prenatal environmental exposures may alter gene expression via epigenetic mechanisms, heritable changes in gene expression occurring without alterations in the DNA sequences.
Specifically current research interest is directed towards health promotion and reducing the risk of disease evaluating the probiotic effects with specific foods and nutrients, and assessing their interactions in optimal combination and food matrix. For this purpose a series of interventions studies evaluate the both the optimal timing of probiotic intervention and the optimal mode of administration.
Sections:
Prenatal
RCT 2 Randomized, parallel-design clinical trial of 3 groups. Pregnant women (n=256) from families with at least one member having an allergic disease have been recruited from maternal welfare clinics and randomly assigned to control group or one of the intervention groups. Mothers in the dietary intervention groups received dietary counselling with specific attention to the quality and quantity of fat in the diet. To promote the achievement of current dietary recommendations, mothers have been provided with foods which have a favourable fat composition (e.g. spreads). The subjects in the intervention groups have been further randomized (double-blind randomization) to receive either placebo or a probiotic preparation, 1010 cfu of both Lactobacillus rhamnosus GG and Bifidobacterium lactis and controls received placebo in a single-blind manner. Dietary food products and probiotic supplementation have been continued from the 1st trimester of pregnancy until the end of exclusive breast feeding, maximum of 6 months.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women from families with at least one family member having an allergic disease
排除标准
- •Women presenting severe immunological or other chronic diseases (rheumatoid arthritis, diabetes, inflammatory bowel disease, thyroid diseases, malignancies etc.)
- •Women who cannot be expected to comply with treatment
- •Women currently participating or having participated in other clinical trial during the last 2 months prior to the beginning of the intervention.
结局指标
主要结局
Number of participants with allergic disease
时间窗: Up to 13 years
Weight gain
时间窗: Up to 13 years
Number of patients with chronic inflammatory disease
时间窗: Up to 13 years
次要结局
- Innate immune gene expression patterns(Up to 13 years)
- Microbiota composition
- Plasma glucose(Up to 13 years)
- Cytokines in peripheral blood(Up to 13 years)
- Cytokine profile in breast milk(Up to 13 years)
- Cytokine profile in peripheral blood mononuclear cells (PBMC)(Up to 13 years)
- GHbA1c(Up to 13 years)
- Fatty acids(Up to 13 years)
- Lipoproteins(Up to 13 years)
- Intakes of foods and nutrients(Up to 13 years)
- Blood pressure(Up to 13 years)
- Leukotrienes in peripheral blood(Up to 13 years)
- Adipokines(Up to 13 years)
- Amount of crying in minutes(Up to 1 year)
- Number of patients with functional gastrointestinal disorders(Up to 13 years)
- Incidence of viral infections(Up to 13 years)
