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Acute Immune Modulation by Probiotic Strain

NCT06754228 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-31

No results posted yet for this study

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.

Conditions

  • Immune Surveillance

Interventions

DIETARY_SUPPLEMENT

Probiotic Agent

Bacillus coagulans JBI-YZ6.3 (BC4U)

DIETARY_SUPPLEMENT

Probiotic Agent

An escalating dose cross-over design: Participants are fed 0 mg, 100 mg, 200 mg, and 400 mg on different clinic visits.

Sponsors & Collaborators

  • Jeneil Biotech Inc.

    collaborator UNKNOWN

  • Natural Immune Systems Inc

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-09-01
Completion
2025-12-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754228 on ClinicalTrials.gov