Recruiting

Probiotic Supplement

Sponsor:

Cambiotics ApS

Code:

NCT07846371

Conditions

Environmental Exposure

PFAS Exposure

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Streptococcus salivarius 46-SL1

Placebo

Study Details

Brief summary:

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.

Conditions

Environmental Exposure

PFAS Exposure

Study ID

NCT07846371

Start date

Oct 8, 2026

Status verified date

Oct, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Sequence A: Study Product then Placebo

Participants consume the probiotic dietary supplement (one capsule twice daily) for 84 days, followed by a 28-day washout, then placebo (one capsule twice daily) for 84 days.

placebo comparator: Sequence B: Placebo then Study Product

Participants consume placebo (one capsule twice daily) for 84 days, followed by a 28-day washout, then the probiotic dietary supplement (one capsule twice daily) for 84 days.

Interventions

Streptococcus salivarius 46-SL1

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

Matching placebo capsule containing microcrystalline cellulose, magnesium stearate and silicon dioxide, consumed twice daily with water for 84 days.

Primary outcome measure

  • Change in serum linear perfluorooctane sulfonic acid (n-PFOS) [ Time Frame: Baseline (Day 0) to Day 84 of each intervention period ]

Central Contacts and Locations

Central contacts

Abigail O'Mahony, Operations Manager

+1 312 535-9440aomahoney@atlantiatrials.com

Stacey Boetto, Princpal Investigator, DNP, FNP-C

312-535-9440sboetto@atlantiatrials.com

Locations

Atlantia Clinical Trials

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Abigail O'Mahony

+1 312 535-9440aomahoney@atlantiatrials.com

sboetto@atlantiatrials.com

Principal Investigator:

Stacey Boetto, DNP, FNP-C

More Information

Sponsor

Cambiotics ApS

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Cross-over study
  • Serum PFAS levels
  • Gut Microbiome
  • Streptococcus salivarius
  • Dietary Supplement
  • Probiotic
  • Occupational Exposure
  • Firefighters
  • Forever Chemicals
  • Per- and Polyfluoroalkyl Substances

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Cambiotics ApS on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.