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NCT06512298Not yet recruiting

Plasticizer Exposure and Its Consequences on Health

Source: ClinicalTrials.gov · Last updated 24 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
6 Jul 2024
Start date
1 Oct 2024
Primary completion date
30 Sept 2027
Lead sponsor
Medical University of Vienna
Diseases
Thalassaemia
NCT number
NCT06512298

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 1 Oct 2024 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.