Plasticizer Exposure and Its Consequences on Health

Study Purpose

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 don't 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

TDTM:

  • - Inclusion: Adult, homozygous ß-Thalassemia Major, transfusion dependency.
  • - Exclusion: Plastic implants, chronic infectious disease, pregnancy.
Thalassemia Intermedia/Minor:
  • - Inclusion: Adult, homozygous/heterozygous ß-Thalassemia Intermedia/Minor.
  • - Exclusion: Plastic implants, chronic infectious disease, pregnancy, transfusion dependency.
Healthy adults:
  • - Inclusion: Adult.
  • - Exclusion: Chronic disease, plastic implants, infectious disease, pregnancy, anemia, medication-, drug-, or alcohol-abuse.
Glioma patients:
  • - Inclusion: Adult, high/low-grade glioma, tumor larger then 3cm, resection with access to the ventricular system.
  • - Exclusion: Large intraventricular hemorrhage, plastic implants, infectious disease.
ICU patients:
  • - Inclusion: Adult, brain hemorrhage, external CSF drain from ventricle.
  • - Exclusion: intraventricular hemorrhage, plastic implants, ECMO, hemodialysis, infectious disease.
Patients undergoing diagnostic lumbar-puncture:
  • - Inclusion: Adult, diagnostic CSF sampling, outpatient setting.
- Exclusion: Ventricular hemorrhage, plastic implants, infectious disease

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06512298
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of Vienna
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Austria
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Beta-thalassemia, Glioma, Healthy Controls, Transfusion-dependent Beta-Thalassemia, Intracranial Hemorrhages, Toxicity
Additional Details

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.

Arms & Interventions

Arms

: Transfusion-dependent thalassemia major (TDTM)

Patients suffering from homozygous transfusion-dependent Thalassemia Major.

: Thalassemia Minor

Patients suffering from heterozygous transfusion-independent Thalassemia Minor.

: Healthy controls

Healthy adult controls without any prevalent substance use (nicotine, alcohol etc.).

: Glioma patients

Adults with high/low-grade glioma, a tumor size > 3cm that require resection with access to the ventricular system without ventricular hemorrhage.

: ICU patients

Adults with brain hemorrhage (intracranial, subdural, subarachnoidal), treated with a ventricular shunt.

: Patients undergoing diagnostic lumbar-puncture (plastic-naive)

Adults that receive a diagnostic lumbar puncture in an outpatient setting.

Interventions

Contact a Trial Team

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International Sites

Medical University of Vienna, Vienna 2761369, Austria

Status

Address

Medical University of Vienna

Vienna 2761369, , 1090

Site Contact

Lukas Wisgrill, MD, PhD

[email protected]

800-123-4567

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