Probiotics, Immunity, Stress, and QofL
Condition: Stress; Quality of Life
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Visit #1

        -  Participants will read and sign informed consent forms, HIPPA form, and SAHP Covid-19
           screening form.

        -  Participants will perform a baseline oral saliva swab to test for the stress biomarker
           cortisol and immune markers, including Interleukin-1β (IL-1β) and Tumor Necrosis Factor
           (TNF).

             -  Swabs will be individually packaged. After opening the package, participants will
                place the swab under their tongue for 1-2 minutes.

             -  After swabbing is complete, the swab will be placed into the collection tube and
                capped immediately.

             -  Completed swabs will be placed and held in a sub negative 70° Fahrenheit freezer.

        -  Participants will complete a Quality-of-Life Questionnaire (10-15 minutes).

        -  As this study is double blinded, participants will be separated by gender (male and
           female) and will select a 90-day supply of placebo or probiotic sample at random. For
           each gender group there will be 50 samples to select from, comprised of a mix of 25
           placebo and 25 probiotic bottles.

        -  Participants will be instructed to take 1 capsule per day for the following 90 days. If
           a participant misses a day, they should resume taking 1 capsule per day the next day.
           The capsule should not be crushed or chewed. The capsule may be taken with or without
           food per participant preference. The participant should consistently take the probiotic
           at a similar time each day (example: always take it in the morning or evening) Visit #2

        -  Participants will complete the same Quality-of-Life Questionnaire from visit #1

        -  Participants will perform a post-study oral saliva swab in the same manner as visit #1
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other