Impact of Parental Training in Endocrine Disruptors on the Excretion of Urinary Biomarkers in Newborns (FLOCON)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endocrine Disruptors in Newborns and Infants
• Intervention / Treatment: Behavioral: Training; Other: Questionnaires; Biological: Urinary dosage

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie PORTEFAIX, Dr; Phone Number: +33 +33472357999; Email: aurelie.portefaix@chu-lyon.fr
• Study Contact Backup: Name: Tiphanie GINHOUX; Phone Number: +33 +33427857723; Email: tiphanie.ginhoux01@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Service de gynécologie obstétrique, Hôpital Femme-Mère-Enfant
    • Contact: Aurélie PORTEFAIX, Dr; Phone Number: +33 +33472357999; Email: aurelie.portefaix@chu-lyon.fr
    • Contact: Cyril HUISSOUD, Pr; Phone Number: +33 04 27 85 56 75; Email: cyril.huissoud@chu-lyon.fr
    • Principal Investigator: Cyril HUISSOUD, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; Parents attending a training course on endocrine disruptors one month after enrolment (Month 1)	Behavioral: Training; Short 4-minute information video on EDs (the investigator present on site during the visit will provide additional information and answer any questions families may have) and a printed brochure (including a list of simple actions to take and reference websites to consult).; Other: Questionnaires; Knowledge and representation questionnaires around EDs Exposure questionnaires Behavior questionnaire HLS-EU16 questionnaire Satisfaction questionnaire; Biological: Urinary dosage; Urinary phtalates dosage
Other: Control group; Parents attending a training course on endocrine disruptors two months after enrolment (Month 2)	Behavioral: Training; Short 4-minute information video on EDs (the investigator present on site during the visit will provide additional information and answer any questions families may have) and a printed brochure (including a list of simple actions to take and reference websites to consult).; Other: Questionnaires; Knowledge and representation questionnaires around EDs Exposure questionnaires Behavior questionnaire HLS-EU16 questionnaire Satisfaction questionnaire; Biological: Urinary dosage; Urinary phtalates dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Month 1, Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Relative variation, between Month 1 and Month 2, in the 'training' group (parents trained at M1) 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	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	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	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Newborns; Urinary biomarkers; Parental training; Endocrine Disruptors; Exposition; Phtalate
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 69HCL24_0017; 2025-A01198-41 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No