Probiotics, Immunity, Stress, and QofL

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063305
• Other study ID #: 5210331
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: February 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Stress

Intervention

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
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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	MeriCal LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Saliva Sample IL-1	Baseline and post-study oral saliva samples will be tested for Interleukin-1ß (IL-1ß) uL.	Change in Interleukin-1ß (IL-1ß) uL between baseline and 90 days
Secondary	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