PesticidePESTIMICOBLAITNCT03969459
Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn
An observational study of Pesticide and Breast Milk, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Epidemiological studies link early exposure to persistent organic pollutants (POPs) with health consequences in the newborn. Experimental studies have shown the impact of POPs on the gut microbiota. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Pesticide, Breast Milk, Pollution; Exposure
- What is being tested?
- breast milk collection, meconium collection and newborn feces collection
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2019to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: 100 mother-child pairs will be included in this project Newborn were born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea. mother are aged of 18 to 42 years old at the time of inclusion
Who may be able to join
- newborn born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea
- mother aged of 18 to 42 years old at the time of inclusion
- mother not deprived of parental rights
- signed concerned consent
- mother having lived for at least 6 months in the Picardie subregion
Who cannot join
- newborn whose term of birth is between 33 and 37 weeks of amenorrhea
- mother minor or aged over 42 years
- mother deprived of her parental rights
Trial locations and contacts
1 site in 1 country.
About this study
Epidemiological studies link early exposure to persistent organic pollutants (POPs) with health consequences in the newborn. Experimental studies have shown the impact of POPs on the gut microbiota. This project aims to characterize the POPs content in breast milk in an exposed population and to evaluate the impact on breast milk composition and intestinal microbiota establishment in the newborn. The health consequences will be evaluated by the clinical follow-up of the newborn.
Read the detailed description
Picardie is a sub-region with a young population and a high birth rate. The highlighting and the characterization of a maternal exhibition and the newborn will make it possible to know the in utero and postnatal exposure to the pesticides, and if necessary, to implement measures of information and prevention adapted to limit it.
The study of pesticide exposure in the periconceptional period, ante and postnatal is crucial because of the vulnerability of this period to the environment and its immediate consequences on the health of the child but also in the long term on the development of chronic pathologies in adulthood. This study will allow us to assess the impact of POPs on the installation of the intestinal microbiota of newborn.
100 mother-child pairs will be included in this project. Samples of 20 mL of breast milk, meconium and stool of newborns will be taken. Gas chromatography or liquid phase analyzes coupled with mass spectrometry will be carried out on breast milk to evaluate the content of persistent organic pollutants and to isolate them. An analysis of the chemical composition of each milk sample will be performed. A bacteriological study for the enumeration of the germs in the mother's milk on the one hand then in the meconium and the saddles of the new-born on the other part will be realized. The DNA of isolated and identified germs will be compared by molecular biology techniques to determine their identity or non-identity within the microbiota of breast milk, meconium and newborn stool. The impact of breast milk contamination by pesticides on the health of newborn will be studied
- Conditions
- Pesticide, Breast Milk, Pollution; Exposure, Meconium, Stool, Microbiota
- Being tested
- breast milk collection, meconium collection, newborn feces collection, questionary of pesticide exposure of the mother
- Keywords
- pesticide exposure, persistent organic pollutants, breast milk, meconium, stool, microbiota, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast milk collectionBiological
3 samples of 20 ml of breast milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
meconium collectionBiological
3 samples of 20 ml of meconium milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
newborn feces collectionBiological
3 samples of 20 ml of newborn feces will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
questionary of pesticide exposure of the motherOther
maternal questionary of pesticide exposure of the mother
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of quantity of pesticides in mother's milk
the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.
Measured: between day 0 and day 4 after childbirth
measure of quantity of pesticides in mother's milk
the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.
Measured: between day 7 and day 15 after childbirth
measure of quantity of pesticides in mother's milk
the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.
Measured: between day 21 and day 30 after childbirth
Secondary outcomes (3)
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk
correlation between pesticides contamination of mother's milk and microbiota composition in mother's milk
Measured: between day 0 and day 4 after childbirth
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk
correlation between pesticides contamination of mother's milk and microbiota composition in mother's milk
Measured: between day 7 and day 15 after childbirth
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk
correlation between pesticides contamination of mother's milk and microbiota composition in mother's milk
Measured: between day 21 and day 30 after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start28 May 2019
- Primary completion28 May 2021
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PesticideStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre Leke, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969459
- Sponsor's protocol ID
- PI2017_843_0032
- Acronym
- PESTIMICOBLAIT
- Status last verified
- Mar 2023
- First submitted
- 28 May 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exposure to Persistent Organic Pollutants During Pregnancy on the Composition of Breast Milk and Consequences on the Newborn
- ClinicalTrials.gov ID
- NCT03969459
- Acronym / sponsor ID
- PESTIMICOBLAIT / PI2017_843_0032
- Conditions
- Pesticide, Breast Milk, Pollution; Exposure, Meconium, Stool, Microbiota
- Keywords
- pesticide exposure, persistent organic pollutants, breast milk, meconium, stool, microbiota, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidemiological studies link early exposure to persistent organic pollutants (POPs) with health consequences in the newborn. Experimental studies have shown the impact of POPs on the gut microbiota. This project aims to characterize the POPs content in breast milk in an exposed population and to evaluate the impact on breast milk composition and intestinal microbiota establishment in the newborn. The health consequences will be evaluated by the clinical follow-up of the newborn.
Detailed description
Picardie is a sub-region with a young population and a high birth rate. The highlighting and the characterization of a maternal exhibition and the newborn will make it possible to know the in utero and postnatal exposure to the pesticides, and if necessary, to implement measures of information and prevention adapted to limit it.
The study of pesticide exposure in the periconceptional period, ante and postnatal is crucial because of the vulnerability of this period to the environment and its immediate consequences on the health of the child but also in the long term on the development of chronic pathologies in adulthood. This study will allow us to assess the impact of POPs on the installation of the intestinal microbiota of newborn.
100 mother-child pairs will be included in this project. Samples of 20 mL of breast milk, meconium and stool of newborns will be taken. Gas chromatography or liquid phase analyzes coupled with mass spectrometry will be carried out on breast milk to evaluate the content of persistent organic pollutants and to isolate them. An analysis of the chemical composition of each milk sample will be performed. A bacteriological study for the enumeration of the germs in the mother's milk on the one hand then in the meconium and the saddles of the new-born on the other part will be realized. The DNA of isolated and identified germs will be compared by molecular biology techniques to determine their identity or non-identity within the microbiota of breast milk, meconium and newborn stool. The impact of breast milk contamination by pesticides on the health of newborn will be studied
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100 mother-child pairs will be included in this project Newborn were born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea. mother are aged of 18 to 42 years old at the time of inclusion
Key inclusion criteria (5 listed)
- newborn born before 33 weeks of amenorrhea or at term born at least 37 weeks of amenorrhea
- mother aged of 18 to 42 years old at the time of inclusion
- mother not deprived of parental rights
- signed concerned consent
- mother having lived for at least 6 months in the Picardie subregion
Key exclusion criteria (3 listed)
- newborn whose term of birth is between 33 and 37 weeks of amenorrhea
- mother minor or aged over 42 years
- mother deprived of her parental rights
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast milk collection3 samples of 20 ml of breast milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth. | Biological | – |
| meconium collection3 samples of 20 ml of meconium milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth. | Biological | – |
| newborn feces collection3 samples of 20 ml of newborn feces will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth. | Biological | – |
| questionary of pesticide exposure of the mothermaternal questionary of pesticide exposure of the mother | Other | – |
Primary outcome
measure of quantity of pesticides in mother's milk
Time frame: between day 0 and day 4 after childbirth
the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.
measure of quantity of pesticides in mother's milk
Time frame: between day 7 and day 15 after childbirth
the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.
measure of quantity of pesticides in mother's milk
Time frame: between day 21 and day 30 after childbirth
the evaluation of the contamination of the mother's milk by pesticides will be done on 20 ml sample of breast milk.
3 secondary outcomes
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk
Time frame: between day 0 and day 4 after childbirth
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk
Time frame: between day 7 and day 15 after childbirth
correlation between measure of quantity of pesticides in mother's milk and microbiota composition in mother's milk
Time frame: between day 21 and day 30 after childbirth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Leke, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pesticide and Breast Milk, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of quantity of pesticides in mother's milk (time frame: between day 0 and day 4 after childbirth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.