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Effect of a Dietary Supplement Versus Placebo on Serum PFAS Levels in Male Firefighters

ConditionsEnvironmental Exposure PFAS Exposure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18+

SponsorCambiotics ApS

About this trial

This study is designed to evaluate the effect of a probiotic dietary supplement containing Streptococcus salivarius on serum PFAS levels in male firefighters with documented occupational PFAS exposure, following twice-daily use over a 12-week period.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Streptococcus salivarius 46-SL1
Dietary supplement
One capsule (\~400 mg live probiotic) consumed twice daily with water, in the morning with breakfast and with the evening meal, for 84 days.
Placebo
Dietary supplement
Matching placebo capsule containing microcrystalline cellulose, magnesium stearate and silicon dioxide, consumed twice daily with water for 84 days.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Sequence A: Study Product then PlaceboExperimental treatment 2 interventions

Group B: Sequence B: Placebo then Study ProductPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in serum linear perfluorooctane sulfonic acid (n-PFOS)

Change in serum n-PFOS concentration (ng/mL) from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

Secondary outcomes

1

Change in pre-specified serum PFAS levels

Change in serum concentrations (ng/mL) of linear PFOA, branched PFOA, PFDoDA, PFUnDA, branched PFOS and PFNA from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

2

Change in composite serum PFAS measure

Change in a composite PFAS measure calculated as the sum of serum PFOS, PFNA and PFDA (ng/mL) from baseline to end of each 84-day intervention period, comparing the probiotic dietary supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

3

Change in gastrointestinal symptoms (GSRS)

Change in Gastrointestinal Symptom Rating Scale (GSRS) total score and the five subscale scores (reflux, abdominal pain, indigestion, diarrhoea, constipation).

Time frame

Baseline (Day 0) to Day 84 of each intervention period

4

Change in fatigue (MFIS)

Change in Modified Fatigue Impact Scale (MFIS) total score, a 21-item self-report measure of the impact of fatigue on physical, cognitive and psychosocial functioning.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

Other outcomes

1

Change in fecal PFAS levels

Change in fecal concentrations of per- and polyfluoroalkyl substances measured by LC-MS/MS, from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

2

Change in fecal microbiome composition

Change in fecal microbiome composition assessed by shotgun metagenomic sequencing, from baseline to end of each 84-day intervention period, comparing the supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

3

Change in fecal metabolite profiles

Change in fecal metabolite panel measured by LC-MS/MS, from baseline to end of each 84-day intervention period, comparing the supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

4

Change in additional serum PFAS biomarkers

Change in serum concentrations (ng/mL) of MeFOSAA and PFHxS from baseline to end of each 84-day intervention period, comparing the supplement with placebo.

Time frame

Baseline (Day 0) to Day 84 of each intervention period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cambiotics ApS

Lead sponsor

Atlantia Food Clinical Trials

Collaborator

Source ClinicalTrials.gov