Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512298
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
Plasticizer Exposure and Its Consequences on Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Plasticizer Exposure and Its Consequences on Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEACH
Brief Summary:
Plasticizers are chemicals commonly found in many everyday items from food packaging to medical equipment Although they are pervasive in our daily lives researchers still dont have a clear picture of their long-term effects on human health Evidence suggests that these substances might disrupt various biological functions such as the immune system the balance of gut bacteria hormone regulation and brain processes While some studies have linked plasticizer exposure to health issues definitive data from human studies are still lacking
The PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health The study focuses on understanding how these chemicals are absorbed distributed and accumulated in the body across different groups of patients The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells as well as their effects on neurotransmitters involved in brain function
A combination of patient data systems biology and laboratory models will be used to thoroughly assess the biological impacts of plasticizers Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties sequencing technologies will be used to examine immune effects and radiouptake assays will be employed to explore interactions with neurotransmitter transport This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers
The PEACH study introduces innovative methods to the field aiming to create a robust model for understanding how plasticizer compounds behave in the human body It employs state-of-the-art techniques to assess the dynamics of these chemicals marking a significant advancement in environmental health research
The PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health The study focuses on understanding how these chemicals are absorbed distributed and accumulated in the body across different groups of patients The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells as well as their effects on neurotransmitters involved in brain function
A combination of patient data systems biology and laboratory models will be used to thoroughly assess the biological impacts of plasticizers Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties sequencing technologies will be used to examine immune effects and radiouptake assays will be employed to explore interactions with neurotransmitter transport This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers
The PEACH study introduces innovative methods to the field aiming to create a robust model for understanding how plasticizer compounds behave in the human body It employs state-of-the-art techniques to assess the dynamics of these chemicals marking a significant advancement in environmental health research
Detailed Description:
Wider research context Industrial plasticizers are ubiquitous in modern society utilized in products ranging from food packaging to medical supplies Despite their widespread use the health implications of chronic plasticizer exposure in humans remain inadequately understood These substances potentially interfere and disrupt various biological processes including immune activity gut microbiota balance endocrinological function and neurophysiological health Current epidemiological or exposure studies were able to pinpoint clinical associations with plasticizer exposures but conclusive mechanistic human in vivo data are missing
Research questions The PEACH study is designed to fill critical gaps in the understanding of the biological implications of plasticizer exposure The investigators aim to analyse the pharmacokinetics of plasticizers in different patient cohorts and elucidate their bioaccumulation distribution and metabolism Thereby the interplay between plasticizer exposure and metabolism gut microbiota composition and immune cell functionality will be explored Furthermore the impact of plasticizer exposure on neurotransmitter physiology will be elucidated
Approach The study employs a comprehensive methodology that integrates the findings from clinical cohorts systems biology approaches and in vitro models Three distinct work packages will examine pharmacokinetic properties via mass spectrometry study immunological effects through advanced sequencing technologies phenotypization and investigate pharmacodynamic interactions with neurotransmitter transporters using human in-vitro assays Longitudinal sampling from acute and chronic exposure cohorts will offer an evolving perspective on effects of plasticizer exposure
Level of originality The PEACH study introduces groundbreaking methodologies and scope to the investigation of plasticizer exposure It aims to support the scientific community with first human in-vivo pharmacokinetic models for these compounds while utilizing high-throughput techniques for pharmacodynamic assessment marking a notable advancement in the field
Research questions The PEACH study is designed to fill critical gaps in the understanding of the biological implications of plasticizer exposure The investigators aim to analyse the pharmacokinetics of plasticizers in different patient cohorts and elucidate their bioaccumulation distribution and metabolism Thereby the interplay between plasticizer exposure and metabolism gut microbiota composition and immune cell functionality will be explored Furthermore the impact of plasticizer exposure on neurotransmitter physiology will be elucidated
Approach The study employs a comprehensive methodology that integrates the findings from clinical cohorts systems biology approaches and in vitro models Three distinct work packages will examine pharmacokinetic properties via mass spectrometry study immunological effects through advanced sequencing technologies phenotypization and investigate pharmacodynamic interactions with neurotransmitter transporters using human in-vitro assays Longitudinal sampling from acute and chronic exposure cohorts will offer an evolving perspective on effects of plasticizer exposure
Level of originality The PEACH study introduces groundbreaking methodologies and scope to the investigation of plasticizer exposure It aims to support the scientific community with first human in-vivo pharmacokinetic models for these compounds while utilizing high-throughput techniques for pharmacodynamic assessment marking a notable advancement in the field
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None