Study of the Passage of (CBD) Into Breast Milk and Its Biological Impact on Breast-fed Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Theoretical dose of CBD received by the breastfed child over 24 hours
研究概览
简要总结
Really few data published to date on the passage of CBD into breast milk. The investigators known that 17.5 percent of the French human being between 18 and 34 years old consume CBD and among this, nearly half are women. None official French data to say how many French breastfeeding mothers consume CBD. CBD is a legal, psychoactive but not psychoaddictive substance. CBD's pharmacokinetic and pharmacodynamics make us fear that CBD could easily go through mother's milk. No published data available on possible effect in breast-fed child, not even on possible biological passage in breast-fed child. The aim of his study is to evaluate the passage of CBD in blood and milk at different moments of the breastfeeding (mothers) and its possible found in the infants'urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Women over 18
- •Breastfeeding CBD user
- •Having given written informed consent
排除标准
- •Women who do not understand French well
- •Women with a psychiatric or dual pathology that prevents proper participation in the study,
- •Women under protective supervision (guardianship/curatorship),
- •Women under court protection,
- •Women not affiliated to a social security scheme
研究组 & 干预措施
breastfeeding mothers with CBD's consumption
Determination of delta 9-tetrahydrocannabinol (THC) and its metabolites , and of cannabidiol and its metabolites in blood and breast-milk by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Realization of THC/CBD ratio; qualitative research in mother's and breast-fed child's urine for the presence of cannabinoids (THC, CBD and its metabolites).
干预措施: Assessing maternal and lactational plasma CBD uptake at different stages of breastfeeding (Biological)
结局指标
主要结局
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Month 12 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Day 2 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Day 21 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Day 42 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Month 3 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Month 4 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Month 6 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
Theoretical dose of CBD received by the breastfed child over 24 hours
时间窗: Month 9 postpartum
Theoretical dose of CBD received by the breastfed child over 24 hours by measuring blood and milk concentrations of CBD during postpartum visits.
次要结局
- impact of ethnicity(Day 2 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Month 3 postpartum)
- Concentration of CBD in maternal blood(Month 12 postpartum)
- Concentration of CBD metabolites in maternal blood(Month 12 postpartum)
- Concentration of CBD in breast-milk(Month 12 postpartum)
- THC concentrations in mother's blood(Month 12 postpartum)
- THC concentrations in breast milk(Month 12 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Month 12 postpartum)
- THC/CBD ratio(Day 2 postpartum)
- Percentage of breastfeeding child with CBD in urine(Month 9 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Month 12 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Month 12 postpartum)
- Concentration of CBD in maternal blood(Day 2 postpartum)
- Concentration of CBD in maternal blood(Day 21 postpartum)
- Concentration of CBD in maternal blood(Day 42 postpartum)
- Concentration of CBD in maternal blood(Month 3 postpartum)
- Concentration of CBD in maternal blood(Month 4 postpartum)
- Concentration of CBD in maternal blood(Month 6 postpartum)
- Concentration of CBD in maternal blood(Month 9 postpartum)
- Concentration of CBD metabolites in maternal blood(Day 2 postpartum)
- Concentration of CBD metabolites in maternal blood(Day 21 postpartum)
- Concentration of CBD metabolites in maternal blood(Month 3 postpartum)
- Concentration of CBD metabolites in maternal blood(Month 4 postpartum)
- Concentration of CBD metabolites in maternal blood(Month 6 postpartum)
- Concentration of CBD metabolites in maternal blood(Month 9 postpartum)
- Concentration of CBD in breast-milk(Day 2 postpartum)
- Concentration of CBD in breast-milk(Day 21 postpartum)
- Concentration of CBD in breast-milk(Day 42 postpartum)
- Concentration of CBD in breast-milk(Month 3 postpartum)
- Concentration of CBD in breast-milk(Month 4 postpartum)
- Concentration of CBD in breast-milk(Month 6 postpartum)
- Concentration of CBD in breast-milk(Month 9 postpartum)
- THC concentrations in mother's blood(Day 2 postpartum)
- THC concentrations in mother's blood(Day 21 postpartum)
- THC concentrations in mother's blood(Day 42 postpartum)
- THC concentrations in mother's blood(Month 3 postpartum)
- THC concentrations in mother's blood(Month 4 postpartum)
- THC concentrations in mother's blood(Month 6 postpartum)
- THC concentrations in mother's blood(Month 9 postpartum)
- THC concentrations in breast milk(Day 2 postpartum)
- THC concentrations in breast milk(Day 21 postpartum)
- THC concentrations in breast milk(Day 42 postpartum)
- THC concentrations in breast milk(Month 3 postpartum)
- THC concentrations in breast milk(Month 4 postpartum)
- THC concentrations in breast milk(Month 6 postpartum)
- THC concentrations in breast milk(Month 9 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Day 2 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Day 21 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Day 42 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Month 3 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Month 4 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Month 6 postpartum)
- Percentage of breastfeeding mother's with CBD metabolites in urine(Month 9 postpartum)
- Percentage of breastfeeding child with CBD in urine(Day 2 postpartum)
- Percentage of breastfeeding child with CBD in urine(Day 21 postpartum)
- Percentage of breastfeeding child with CBD in urine(Day 42 postpartum)
- Percentage of breastfeeding child with CBD in urine(Month 3 postpartum)
- Percentage of breastfeeding child with CBD in urine(Month 4 postpartum)
- Percentage of breastfeeding child with CBD in urine(Month 6 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Day 2 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Day 21 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Day 42 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Month 3 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Month 4 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Month 6 postpartum)
- Percentage of breastfeeding child with CBD metabolites in urine(Month 9 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Day 2 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Day 21 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Day 42 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Month 4 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Month 6 postpartum)
- Percentage of breastfeeding mother's with CBD in urine(Month 12 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Day 2 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Day 21 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Day 42 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Month 3 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Month 4 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Month 6 postpartum)
- Percentage of breastfeeding mother's with THC in urine(Month 9 postpartum)