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Probiotic Bacillus coagulans JBI-YZ6.3 (BC4U) for Immune Surveillance

This study is looking at how a probiotic called Bacillus coagulans JBI-YZ6.3 (BC4U) affects your immune system right after you take it. Researchers want to see if different amounts (0 mg, 100 mg, 200 mg, and 400 mg) of this probiotic can change how your immune system communicates. They will measure this immune communication 3 hours after you take the probiotic. This study is for healthy adults between 18 and 75 years old who have easily visible veins for blood draws and are willing to follow specific diet and lifestyle routines. The study aims to understand the immediate impact of this probiotic on your immune function compared to a placebo (an inactive substance). The current recruitment status is unclear.

Study design
This is a clinical proof-of-concept study involving 24 healthy adults. It uses an escalating dose, cross-over design, meaning participants will receive a placebo and three different doses of the probiotic at different times.
What's involved
You would need to maintain a consistent diet and lifestyle, eat bland breakfasts on clinic visit days, and avoid exercise and certain nutrition. Blood samples will be taken multiple times during each visit, before and after taking the probiotic.
Compensation
Not stated in the trial record.
Follow-up
Immune communication is measured at 3 hours after taking the probiotic.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06754228

Acute Immune Modulation by Probiotic Strain

Completed
NAAges 18–75InterventionalBasic science
Natural Immune Systems Inc
~12 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Probiotic Agent

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immune communication
Measured over 3 hours

Conditions

Immune Surveillance

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Oregon1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Healthy adults;
Age 18-75 years (inclusive);
Veins easy to see in one or both arms (to allow for the multiple blood draws);
Willing to comply with study procedures, including:
Maintaining a consistent diet and lifestyle routine throughout the study,
Consistent habit of bland breakfasts on days of clinic visits,
Abstaining from exercising and nutritional supplements on the morning of a study visit,
Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion

Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
Taking anti-inflammatory medications on a daily basis;
Currently experiencing intense stressful events/ life changes;
Currently in intensive athletic training (such as marathon runners);
Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
Unwilling to maintain a constant intake of supplements over the duration of the study;
Anxiety about having blood drawn;
Pregnant, nursing, or trying to become pregnant;
Known food allergies related to ingredients in active test product or placebo.

What this trial measures

  • Immune communication3 hours

    Changes in serum cytokine levels