RecruitingNot ApplicableNCT06754228

Acute Immune Modulation by Probiotic Strain

Acute Immune Modulation by Probiotic Strain Bacillus Coagulans JBI-YZ6.3 (BC4U)

Sponsor

Natural Immune Systems Inc

Enrollment

24 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Immune Surveillance

Summary

Clinical proof-of-concept study, comparing the acute immune impacts of 3 doses of a probiotic strain to a placebo. This study involves twenty-four participants, composed of healthy adults, who will be taking a placebo and 3 different doses of the probiotic at different times. Testing for immune status and cytokine levels will be conducted to determine the acute impact of the probiotic on immune function when compared to a placebo.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria10

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.

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