Maternal and Newborn Exposure to Mycotoxins in Israel and the Association to Baby's Development in First Months of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mycotoxins in breastmilk
研究概览
简要总结
Some plant pathogen fungi may develop in grains, nuts and dry foodstuff during their storage. They secrete toxins which are very resistant and persistent.
The toxins enter the human body through the food. Women eating without their knowledge spoiled food absorb the toxin which is conveyed into their milk. In the same way, meat and dairy products can be contaminated with mycotoxins.
Toxins and their metabolites can have negative effects on pregnant women and on the fetus or infant health.
The main purpose of this trial is to assess the presence of toxins in mothers's milk.
详细描述
Fungi from the genus Aspergillus, Penicillium, Fusarium and Alternaria can synthesize toxins. These may be carcinogenic, immunotoxic or endocrine disruptors.
In this trial, Zearalenone, Deoxynivalenol, T-2 toxin, Fumonisin B1, Fumonisin B2, Aflatoxin M1, Aflatoxin B1, Aflatoxin B2, Aflatoxin G1, Aflatoxin G2, Ochratoxin A, HT-2 toxin, De-epoxy-deoxynivalanol presence and quantity will be assessed in mother's milk.
Another purpose is to try to pinpoint at the source(s) of contamination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 and above.
- •Pregnant women after week 37 intending to breastfeed.
- •Women breastfeeding.
排除标准
- •Women taking drugs which influence milk production.
- •Women taking drugs contraindicated during breastfeeding.
- •Women not staying in Israel during third trimester or in the months after birth for a long period of time.
- •Women not wanting/able to fill up the questionnaires.
结局指标
主要结局
Mycotoxins in breastmilk
时间窗: approx. 6 months after recruitment
To measure mycotoxins and mycotoxins metabolites levels in breast milk
次要结局
- Source of contamination(approx. one year after recruitment)