跳至主要内容
临床试验/NCT07349927
NCT07349927招募中不适用

Impact of Parental Training in Endocrine Disruptors on the Excretion of Urinary Biomarkers of Exposure: a Randomised Controlled Pilot Study With Two Parallel Arms

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年3月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Comparison of the variation in urinary Mono-n-butyl-phthalate (MBP) levels in infants in the 'training' group versus the 'control' group between Month 1 and Month 2

研究概览

简要总结

The impact of the environment on health, responsible for a quarter of all deaths worldwide and costing more than €160 billion a year, is difficult to assess because of the complexity of exposure and interactions. Endocrine disrupters (EDs), which are omnipresent in our daily lives, affect hormone metabolism and can have long-term consequences, including effects on subsequent generations. Although complete avoidance is impossible, it is possible to reduce exposure through simple measures.

EDs can be divided into two groups: those with a short half-life, which are rapidly eliminated through the urine, and those with a long half-life, such as PFAS (Per- and polyfluoroalkyl substances), which accumulate in the body. Short-half-life EPs are particularly interesting for interventional studies, as their rapid elimination means that the impact of actions can be measured in a few days.

Policies to combat EDs, such as phthalate-free cities, have been put in place, but impact assessments are still needed. The national plan to combat EDs is based on improving public knowledge, collecting data on impregnation and looking for alternatives.

Studies show that modifying diet and personal care products can reduce concentrations of ED biomarkers, but the results are difficult to transpose to France. The 'first 1,000 days' (pregnancy, birth, infancy) are a window of vulnerability, providing an ideal opportunity to provide information and reduce exposure.

Environmental health research focuses on assessing exposure using biomarkers and informing the public. Studies on newborns and infants, which are still rare, are essential for a better understanding of the risks. Interventions to limit exposure to EDs with short half-lives can have rapidly measurable effects, and randomised studies are needed to test these reduction strategies.

The hypothesis of the study is that practical parental training in simple gestures can reduce the urinary excretion of short-half-life EDs in infants.

This study will therefore provide data on the exposure of infants prior to dietary diversification and assess the impact of parental information on urinary ED levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
0 Days 至 5 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns born at the Bron hospital after 37 weeks of amenorrhea
  • Eutrophic
  • Affiliated to a social security scheme or beneficiary of a similar scheme
  • Consent signed by parents

排除标准

  • Congenital anomaly diagnosed antenatally or postnatally
  • Parents who do not speak French

研究组 & 干预措施

Training group

Experimental

Parents attending a training course on endocrine disruptors one month after enrolment (Month 1)

干预措施: Training (Behavioral)

Training group

Experimental

Parents attending a training course on endocrine disruptors one month after enrolment (Month 1)

干预措施: Questionnaires (Other)

Training group

Experimental

Parents attending a training course on endocrine disruptors one month after enrolment (Month 1)

干预措施: Urinary dosage (Biological)

Control group

Other

Parents attending a training course on endocrine disruptors two months after enrolment (Month 2)

干预措施: Training (Behavioral)

Control group

Other

Parents attending a training course on endocrine disruptors two months after enrolment (Month 2)

干预措施: Questionnaires (Other)

Control group

Other

Parents attending a training course on endocrine disruptors two months after enrolment (Month 2)

干预措施: Urinary dosage (Biological)

结局指标

主要结局

Comparison of the variation in urinary Mono-n-butyl-phthalate (MBP) levels in infants in the 'training' group versus the 'control' group between Month 1 and Month 2

时间窗: Month 1, Month 2

Comparison of the variation in urinary Mono-n-butyl-phthalate (MBP) levels in infants in the 'training' group versus the 'control' group between Month 1 and Month 2

次要结局

  • Relative variation, between Month 1 and Month 2, in the 'training' group (parents trained at Month 1) compared to the 'control' group, in urinary concentrations of : Mono(2-ethyl-5-oxohexyl)-phthalate also called 5-oxo-MEHP(Month 1, Month 2)
  • Relative variation, between Month 1 and Month 2, in the 'training' group (parents trained at Month 1) compared to the 'control' group, in urinary concentrations of Mono(2-ethyl-5-hydroxyhexyl)-phthalate also called 5-OH-MEHP(Month 1, Month 2)
  • Relative variation between Month 1 and Month 2 in the 'training' group (parent training at Month 1) compared with the 'control' group, in urinary concentration of Mono(5-carboxy-2-ethylpentyl)-phthalate also called 5-cx-MEPP(Month 1, Month 2)
  • Relative variation, between Month 1 and Month 2, in the 'training' group (training of parents at Month 1) compared to the 'control' group, in urinary concentrations of Mono[2-(carboxymethyl)hexyl]-phthalate also called 2-cx-MMHP(Month 1, Month 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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