Status:

RECRUITING

Acute Immune Modulation by Probiotic Strain

Lead Sponsor:

Natural Immune Systems Inc

Collaborating Sponsors:

Jeneil Biotech Inc.

Conditions:

Immune Surveillance

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief 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...

Detailed Description

Clinical proof-of-concept study comparing the acute immune effects of 3 doses of a probiotic compared to a placebo. The probiotic strain is characterized as Bacillus coagulans JBI-YZ6.3 (BC4U). 24 su...

Eligibility Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Key Trial Info

Start Date :

November 13 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 15 2025

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT06754228

Start Date

November 13 2024

End Date

December 15 2025

Last Update

December 31 2024

Active Locations (1)

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1

NIS Labs

Klamath Falls, Oregon, United States, 97601