NCT06754228 · Natural Immune Systems Inc
Acute Immune Modulation by Probiotic Strain
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Immune communication
Time frame: 3 hours
Changes in serum cytokine levels
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Klamath Falls, Oregon
Collaborators
Jeneil Biotech Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 31, 2024 · Source of record for eligibility and locations