Probiotics, Immunity, Stress, and QofL

The Efficacy of Probiotics on Immune and Stress Response and Overall Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Stress
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and Females
• 18-90 years of age
• Participants should be of good health

Exclusion Criteria:

• Women who are self-reported as pregnant and/or breastfeeding
• Those who suffer from any systemic illness, such as diabetes mellitus, HIV, cancer, or chronic kidney disease.
• Persons who are diagnosed with clinical depression or anxiety, or other mental health diagnoses such as schizophrenia or Alzheimer's.
• Persons who have taken any probiotic for 5 or more days in the 3 months prior to the trial
• Persons having received antibiotics or non-steroid anti-inflammatory therapy in the last 3-month period prior to the study
• Persons who work night shift
• Persons who consume probiotic rich foods daily, such as yogurt, kimchi, kombucha, kefir, sauerkraut, tempeh, miso, and buttermilk
• Anyone who is allergic to any ingredient in the probiotic or placebo

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Male Probiotic; • 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 capsule at a similar time each day (example: always take it in the morning or evening)	Dietary supplement: Probiotic; 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).
Placebo Comparator: Male Placebo; • 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 capsule at a similar time each day (example: always take it in the morning or evening)	Dietary supplement: Placebo; 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.
Experimental: Female Probiotic; • 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 capsule at a similar time each day (example: always take it in the morning or evening)	Dietary supplement: Probiotic; 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).
Placebo Comparator: Female Placebo; • 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 capsule at a similar time each day (example: always take it in the morning or evening)	Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva Sample Cortisol	Baseline and post-study oral saliva samples will be tested for the stress biomarker cortisol uL.	Change in cortisol uL between baseline and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva Sample IL-1	Baseline and post-study oral saliva samples will be tested for Interleukin-1β (IL-1β) uL.	Change in Interleukin-1β (IL-1β) uL between baseline and 90 days
Saliva Sample Tumor Necrosis Factor	Baseline and post-study oral saliva samples will be tested for Tumor Necrosis Factor (TNF) uL.	Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: MeriCal LLC
• Investigators: Principal Investigator: JeJe Noval, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): January 27, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 5210331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No