Loma Linda University
Loma Linda, California, 92350, United States
NCT Number: NCT05063305
The purpose of this graduate student research study is to evaluate the efficacy of a multi-strain probiotic and investigate if sex differences influence the role of probiotics on stress and immunity biomarkers.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Loma Linda, California, 92350, United States
Visit #1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The probiotic to be used in the study is in capsule form and consists of 12 bacterial strains and 10-billion colony forming unit (CFU). The product consists of the following bacterial strains and species: Bifidobacterium infantis ATCC SD 6720, Bifidobacterium bifidum ATCC SD 6576, Bifidobacterium breve ATCC SD 5206, Bifidobacterium lactis ATCC SD 5220, Bifidobacterium longum ATCC SD 5588, Lactobacillus acidophilus DSM 32754, Lactobacillus casei ATCC SD5213, Lactobacillus paracasei ATCC SD 5275, Lactobacillus plantarum ATCC SD 5209, Lactobacillus reuteri ATCC SD 6689, Lactobacillus rhamnosus ATCC 53103, Lactobacillus salivarius ATCC SD 5208) in combination with the prebiotic, xylooligosacharide (XOS).
A placebo, that will be indistinguishable in appearance to the probiotic, will be provided to half of all study participants for the length of the trial. It will contain the following ingredients: Microcrystalline cellulose, magnesium stearate, a vegetarian capsule, and silicon dioxide. The probiotic will be manufactured by MeriCal.
Time frame: Change in cortisol uL between baseline and 90 days
Baseline and post-study oral saliva samples will be tested for the stress biomarker cortisol uL.
Time frame: Change in Interleukin-1β (IL-1β) uL between baseline and 90 days
Baseline and post-study oral saliva samples will be tested for Interleukin-1β (IL-1β) uL.
Time frame: Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days
Baseline and post-study oral saliva samples will be tested for Tumor Necrosis Factor (TNF) uL.
Loma Linda University
Other
The Efficacy of Probiotics on Immune and Stress Response and Overall Quality of Life
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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