Probiotic supplement to lower serum PFAS levels in male firefighters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, crossover pilot study evaluating whether a probiotic containing Streptococcus salivarius 46-SL1 can reduce serum PFAS levels in men with occupational PFAS exposure. Participants will use the probiotic or placebo twice daily for 12 weeks, followed by a 4-week washout, then switch to the other arm for another 12 weeks. Researchers will measure serum PFAS levels, gastrointestinal symptoms, fatigue, and analyze stool samples across eight study visits. The design allows each participant to serve as their own control to compare the probiotic versus placebo. Safety monitoring and questionnaires are included to contextualize biomarker changes with symptom data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to give written informed consent
* Male firefighter with previous career exposure to PFAS
* BMI between 18.5 and 35 kg/m²
* Serum PFOS level ≥5 ng/mL at screening
* Willing to consume the study product daily for the duration of the study

Exclusion Criteria:

* History of drug and/or alcohol abuse (\>15 standard drinks per week)
* Food allergy, intolerance or dietary restriction that, in the opinion of the investigator, would preclude consumption of the study product
* Blood donation within the past 3 months
* Current smoker of \>20 cigarettes per day, or former smoker with a history of ≥20 cigarettes per day who quit within 6 months prior to Visit 1
* Any significant acute or chronic health condition that would prevent participation, pose a risk, or confound interpretation of results, including: diagnosed gastrointestinal disorders (irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, ulcerative colitis, coeliac disease, or other chronic diarrhoeal disorders); uncontrolled medical conditions; history of chronic kidney or liver disease; chronic inflammatory or autoimmune disease; history of gastrointestinal surgery; hospitalisation within the past 3 months
* Current or recent (past 12 weeks) use of medications affecting bile acid metabolism (e.g. bile acid sequestrants, fibrates) or antibiotics
* Current or recent (past 4 weeks) use of supplements affecting gut microbiota (prebiotics, probiotics, postbiotics, fibres, synbiotics), detoxification pathways (milk thistle, N-acetylcysteine, glutathione) or bile acid metabolism (e.g. psyllium husk)
* Current or recent (past 2 weeks) consumption of prohibited foods, including probiotic yoghurts
* Considered by the investigator unlikely to comply with study requirements
* Current participation in another clinical study, or insufficient time elapsed since a previous experimental study

Where it's running

• Atlantia Clinical Trials
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Stacey Boetto, DNP, FNP-C — Atlantia Food Clinical Trials
• Study coordinator: Abigail O'Mahony, Operations Manager
• Email: aomahoney@atlantiatrials.com
• Phone: +1 312 535-9440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.