Acute Immune Modulation by Probiotic Strain

Part of paid clinical trials in Klamath Falls, Oregon.

Sponsor
Natural Immune Systems Inc
Study ID
NCT06754228
Status
Recruiting
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Conditions

  • Immune Surveillance

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Probiotic Agent — DIETARY_SUPPLEMENT
    Bacillus coagulans JBI-YZ6.3 (BC4U)
  • Probiotic Agent — DIETARY_SUPPLEMENT
    An escalating dose cross-over design: Participants are fed 0 mg, 100 mg, 200 mg, and 400 mg on different clinic visits.

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Nov 2024
Primary completion
Sep 1, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental Group A
    Crossover study: Participants will be consuming placebo on the first clinic visit, a low dose of the probiotic on the second clinic visit, a medium dose of the probiotic on the third clinic visit, and a high dose of the probiotic on the fourth clinic visit. Each clinic visit is separated by at least 1 week wash-out period.

Primary Outcome Measure

Immune communication [ Time Frame: 3 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
NIS LabsKlamath FallsOregon97601
Alex Cruickshank
[email protected]
541-884-0112
Gitte S Jensen (PRINCIPAL_INVESTIGATOR)

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NIS Labs· Klamath Falls, OR

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