Clinical trial NCT05063305: Probiotics, Immunity, Stress, and QofL
Official title: The Efficacy of Probiotics on Immune and Stress Response and Overall Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Quality of Life
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: MeriCal LLC
First posted: 2021-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Saliva Sample Cortisol
timeFrame: Change in cortisol uL between baseline and 90 days
Secondary outcomes:
measure: Saliva Sample IL-1
timeFrame: Change in Interleukin-1β (IL-1β) uL between baseline and 90 days
measure: Saliva Sample Tumor Necrosis Factor
timeFrame: Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: JeJe Noval, PhD
role: PRINCIPAL_INVESTIGATOR
References: