Clinical trial NCT02210299: TEXTO : Total EXposure To Organic Pollutants
Official title: TEXTO : Total EXposure To Organic Pollutants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: Healthy young children (2-6 months ; 12-18 months)
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé, Environnement et le Travail, France
name: Laboratoire d'Etude des Résidus et Contaminants dans les Aliments
name: Institut national de l'environnement industriel et des risques
name: National Agency for Sanitary Safety of the Food of the Environment and Labor
First posted: 2014-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact...), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.

In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.

The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.

Detailed description: Pilot study for testing feasibility of cross sectional integrative exposure study.

Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).

Expected outcomes :

Assessment of feasibility to obtain:

* original data on children's body burden
* original contamination data for food, water, air and dust ;
* Matching of these data to identify main sources and pathways of exposure.

Eligibility criteria: Inclusion Criteria:

Young children (2-6 months ; 12-18 months)

* In outpatient pediatric or pediatric surgery ;
* From their homes ;
* With home located less than 30km from Rennes ;
* Living at their home (not at childcare facility or child-minder);
* With a scheduled blood sampling apart from this study ;
* For child 2 - 6 months :
* With diet exclusively based on milk (maternal exclusively or commercial exclusively)
* In case of breastfeeding, with mother accepting milk sampling ;
* With a free, enlightened and signed written consent from the parents.

Breastfeeding mother :

* \> 18 years ;
* Exclusive breastfeeding ;
* With a free, enlightened and signed written consent.

Exclusion Criteria:

Children :

* Metabolic illness ;
* Renal or hepatic insufficiency ;
* Malabsorption
* With known HIV+, HBV+, HCV+, CMV+ serology
* Simultaneously participating to other biomedical survey

For breastfeeding mother :

* Under legal protection (judicial protection, guardianship) ;
* mixed breastfeeding ;
* with Known HIV+, HBV+, HCV+, CMV+ serology

Primary outcomes:
measure: Feasibility recruitment
timeFrame: 3 months
Secondary outcomes:
measure: Protocol validation
timeFrame: 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes Hospital University
state: Brittany
Study officials:
affiliation: Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le Travail
name: Philippe Glorennec, PhD
role: STUDY_CHAIR
affiliation: Rennes University Hospital
name: Florence Rouget, MD
role: PRINCIPAL_INVESTIGATOR
References: