Probiotics, Immunity, Stress, and QofL

NCT05063305 | Completed

• 1 other identifier: 5210331
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Saliva Sample IL-1

  Change in Interleukin-1β (IL-1β) uL between baseline and 90 days

• Saliva Sample Tumor Necrosis Factor

  Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days

Study Arms (4)

Male Probiotic

EXPERIMENTAL

• 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

Male Placebo

PLACEBO COMPARATOR

• 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

Female Probiotic

EXPERIMENTAL

• 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

Female Placebo

PLACEBO COMPARATOR

• 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

Interventions

Probiotic DIETARY_SUPPLEMENT

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).

Female Probiotic; Male Probiotic

Placebo DIETARY_SUPPLEMENT

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.

Female Placebo; Male Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• MeriCal LLC: collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• JeJe Noval, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Nutrition and Dietetics

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 1, 2021
• Study Start: September 27, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

US (1)