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Enrolling By Invitation NCT07658443

Evaluating DFPP for Microplastic and PFAS Reduction

Conditions: Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 20
Sponsor: Proxima Health, Inc.

Location: Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne Obergünzburg

Summary

This prospective, non-interventional, within-subject paired biomarker study will evaluate whether circulating microplastic and nanoplastic-associated particle concentrations and PFAS concentrations in peripheral blood change after clinically prescribed double-filtration plasmapheresis (DFPP). Twenty adult volunteers already undergoing DFPP independent of research participation will provide paired pre- and post-treatment blood samples. The primary endpoints are within-participant change in microplastic and nanoplastic-associated particle concentration measured by nano-flow cytometry with Nile Red staining, and PFAS concentration measured by LC-MS/MS. An exploratory subset of five participants will undergo Py-GC-MS analysis of paired blood samples and DFPP eluate to evaluate polymer-specific mass changes and the presence of plastic polymers in eluate, and LC-MS/MS to evaluate the presence of PFAS in eluate. DFPP treatment decisions and procedural parameters are determined solely by the treating physician as part of routine care.

Eligibility Criteria

Inclusion Criteria: * Age 18 to 80 years * Body weight greater than 40 kg (approximately 88 lb) * Already independently prescribed DFPP treatment by a qualified treating clinic * Able to understand the study and provide voluntary informed consent * Willing and able to provide blood samples before and after DFPP treatment * Cleared for DFPP by the prescribing clinic * Has not had plasmapheresis treatment within the past 7 days Exclusion Criteria: * Not yet prescribed DFPP by a treating clinic * Major heart or circulatory problems, such as recent myocardial infarction or hypertensive crisis * Serious kidney or liver impairment * Blood-clotting disorders or significantly impaired coagulation * Active infection, inflammation, or fever * Severe frailty or very poor medical condition * Anemia with hemoglobin below 8 g/dL * Body weight under 40 kg * Pregnancy or breastfeeding * Determined by the treating clinic to be medically or mentally inappropriate for DFPP

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07658443). StuddyBuddy aggregates publicly available trial information.