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