Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-01 @ 3:36 AM
Study NCT ID:
NCT05063305
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics, Immunity, Stress, and QofL
Sponsor:
Loma Linda University
Organization:
Study Overview
Official Title:
The Efficacy of Probiotics on Immune and Stress Response and Overall Quality of Life
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: