Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
研究概览
简要总结
In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal term pregnancy
- •Lactating women
- •Healthy breastfed infant
- •Women with mastitis:
- •Clinical symptoms of mastitis
- •Painful breastfeeding
- •Count of staphylococci, streptococci and/or corynebacteria in milk higher than 3,000 colony-forming units/mL
- •Leukocyte count in milk higher 6 log10/mL
- •Women without mastitis:
- •No clinical symptoms of mastitis
- •No painful breastfeeding
- •Count of staphylococci, streptococci and/or corynebacteria in milk lower than 500 colony-forming units/mL
- •Leukocyte count in milk lower 5 log10/mL
排除标准
- •Allergy to cow's milk protein
- •Intolerance to lactose
- •Antibiotic treatment
- •Breast abscess
- •Raynaud syndrome
- •Any parallel disease
结局指标
主要结局
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts
时间窗: one week
Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk
次要结局
- Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples(one year)
- Evidence of Changes in the Immunological Profile of Milk(one year)
- Evidence of Changes in the Metabolic Profile of Urine(One year)
- Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk(One year)
研究者
Juan M. Rodríguez
Professor, PhD
Universidad Complutense de Madrid