70 Participants NeededMy employer runs this trial

Probiotic Supplement for Forever Chemicals Exposure

(AFCRO202 Trial)

AO
SB
Overseen ByStacey Boetto, Princpal Investigator, DNP, FNP-C

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a probiotic supplement, specifically Streptococcus salivarius 46-SL1, can reduce PFAS levels in the blood of male firefighters exposed to these chemicals on the job. PFAS, often called "forever chemicals," persist in the body and may impact health. Participants will take either the probiotic or a placebo (a capsule that looks identical but contains no active ingredient) for 12 weeks, then switch to the other option after a break. Male firefighters with a history of PFAS exposure and a specific PFOS level may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on reducing harmful chemical exposure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Without specific data on Streptococcus salivarius 46-SL1, considering the broader context is beneficial. Probiotics, such as Streptococcus salivarius, are generally well-tolerated by most individuals and are often included in dietary supplements to support gut health. Although the specific strain 46-SL1 is under investigation, probiotics typically have a strong safety record. Side effects, if any, are usually mild, such as stomach upset or gas. The trial's unspecified phase suggests that researchers are still exploring the treatment's safety, making monitoring during the study crucial to ensure safety.12345

Why are researchers excited about this trial?

Unlike traditional treatments for exposure to "forever chemicals," which primarily involve avoidance and detoxification strategies, the probiotic supplement Streptococcus salivarius 46-SL1 offers a novel approach by potentially supporting the body's natural microbiome to mitigate the effects. This treatment is unique because it uses a specific strain of probiotic bacteria that may help reduce the body's absorption of these persistent chemicals. Researchers are excited about this treatment as it represents a shift from reactive to proactive management, possibly providing a more natural and holistic option to combat the long-term health effects of these environmental pollutants.

What evidence suggests that this probiotic supplement could be effective for reducing PFAS levels in firefighters?

This trial will evaluate the effects of Streptococcus salivarius 46-SL1, a beneficial bacterium, on reducing PFAS levels in the body. Known as "forever chemicals," PFAS do not break down easily and are linked to health issues such as cancer and hormone problems. Participants will receive the probiotic dietary supplement in one sequence and a placebo in another. Early studies suggest that these probiotics might bind to PFAS in the gut, aiding their removal from the body. Although research on Streptococcus salivarius and PFAS continues, this approach shows promise for mitigating PFAS exposure effects. This could be particularly beneficial for individuals with high occupational exposure, such as firefighters.678910

Who Is on the Research Team?

SB

Stacey Boetto, DNP, FNP-C

Principal Investigator

Atlantia Food Clinical Trials

EG

Emilie Glad Bak, PhD

Principal Investigator

Cambiotics ApS

KK

Klavs Kirk

Principal Investigator

Cambiotics ApS

Are You a Good Fit for This Trial?

This trial is for male firefighters who have been exposed to PFAS chemicals at work. Participants must be able to take a dietary supplement twice daily for 12 weeks.

Inclusion Criteria

Able to give written informed consent
Serum PFOS level ≥5 ng/mL at screening
I am a male firefighter who has been exposed to PFAS at work.
See 2 more

Exclusion Criteria

I have used supplements that affect my gut or digestion in the past 4 weeks.
Current participation in another clinical study, or insufficient time elapsed since a previous experimental study
Current or recent (past 2 weeks) consumption of prohibited foods, including probiotic yoghurts
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment Period 1

Participants receive either the probiotic dietary supplement or placebo for 84 days

12 weeks
3 visits (in-person), 1 call

Washout

A 28-day washout period between crossover phases

4 weeks

Treatment Period 2

Participants receive the alternate treatment (placebo or probiotic dietary supplement) for 84 days

12 weeks
3 visits (in-person), 1 call

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Streptococcus salivarius 46-SL1

Trial Overview

The study compares a probiotic supplement containing Streptococcus salivarius with a placebo to see if it can lower PFAS levels in the blood of male firefighters over 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Sequence A: Study Product then PlaceboExperimental Treatment2 Interventions
Group II: Sequence B: Placebo then Study ProductPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cambiotics ApS

Lead Sponsor

Atlantia Food Clinical Trials

Industry Sponsor

Trials
43
Recruited
4,300+

Citations

Per- and Polyfluoroalkyl Substance Toxicity and Human ...

Epidemiological studies have revealed associations between exposure to specific PFAS and a variety of health effects, including altered immune and thyroid ...

New EPA data show millions more exposed to 'forever ...

New data released by the Environmental Protection Agency shows more than 11 million additional people have the toxic “forever chemicals” ...

PFAS (Forever Chemicals)

Exposure to trace amounts of PFAS can cause serious health problems, including cancer, infertility, developmental delays in children, hormone disruption, high ...

The State of PFAS Forever Chemicals in America (2024)

PFOS and PFOA levels in blood have declined by more than 85% and 70%, respectively, since 1999 but there are concerns that Americans are being ...

Human Exposure: PFAS Information for Clinicians - 2024

This page covers PFAS epidemiology, exposure sources and routes, and drinking water standards, regulations, and health.

The Avalon Project : Federalist No 46

The prepossessions, which the members themselves will carry into the federal government, will generally be favorable to the States; whilst it will rarely happen ...

45 CFR Part 46 -- Protection of Human Subjects

New Finding Aids are now available on eCFR.gov. The Parallel Table of Authorities, Subject Index, and Agency-prepared Indexes are now online! Learn more.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40774265/

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ...

These results confirm the safety and potential of [68Ga]Ga-FAPI-46 PET as an imaging biomarker for the detection of FAP-expressing tumours.

Title 46 RCW:

Vehicle and driver data. Transportation of hazardous materials. 46.52 Accidents—Reports—Abandoned vehicles. Hotline 1-800-562-6000 … line Studies, audits, and ...

U.S. Code: Title 46 — SHIPPING - Law.Cornell.Edu

Title 46 or Title 46 Appendix. Former Sections. Title 46. New Sections. 1. Rep. 2 ... Safety Act [Pub. L. 92–340, former 33 U.S.C. 1221 et seq.] to title 46 ...