The goal of this clinical trial is to test to efficacy of a probiotic blend on stress in adolescents with moderate perceived stress. It is hypothesized that those taking the probiotic blend will have decreased levels of stress compared to those receiving the placebo.
Participants in this randomized, double-blind, placebo-controlled, parallel study will be adolescents with moderate perceived stress. Participants will be enrolled in this study for 63 days, with a 56-day intervention period and a 7 day follow-up period. There will be a total of 5 visits: 4 in-person and 1 follow-up phone call.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
30
Participants will be taking 1 sachet a day, 3 billion CFU.
Participants will be taking 1 sachet a day.
KGK Science Inc.
London, Ontario, Canada
Change in stress at day 56 from baseline
The difference in change from baseline in stress at Day 56 between Probiotic and Placebo measured by the Perceived Stress Scale (PSS). The PSS is a validated and commonly used tool to measure perceived stress. Responses are rated by participants on a 5-point Likert scale. The PSS-10 has been reported to be superior to other versions of the scale and will be used in this study. The total score of PSS-10 ranges between 0-40. Scores between 0-13 are considered low stress, 14-26 are considered moderate stress, and 27-40 are considered high stress.
Time frame: 56 days
Change in stress at day 28 from baseline
The difference in change from baseline in stress at Day 28 between Probiotic and Placebo measured by the Perceived Stress Scale (PSS) The PSS is a validated and commonly used tool to measure perceived stress. Responses are rated by participants on a 5-point Likert scale. The PSS-10 has been reported to be superior to other versions of the scale and will be used in this study. The total score of PSS-10 ranges between 0-40. Scores between 0-13 are considered low stress, 14-26 are considered moderate stress, and 27-40 are considered high stress.
Time frame: 28 days
Change in sleep quality from baseline
The difference in change from baseline at Days 28 and 56 between Probiotic and Placebo in sleep quality as assessed by the Adolescent Sleep-Wake Scale (ASWS). The ASWS is a 28-item scale developed to assess self-reported sleep quality in individuals 12-18 years old. The scale is comprised of five behavioral dimensions including going to bed (5 questions), falling asleep (6 questions), maintaining sleep (6 questions), reinitiating sleep (6 questions), and returning to wakefulness (5 questions). Respondents are instructed to provide responses based on the past month on a six-point Likert scale ranging from always (score=1) to never (score=6). Higher scores representing better sleep quality.
Time frame: 56 days
Change in daytime sleepiness from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The difference in change from baseline at Day 28 and 56 between Probiotic and Placebo in daytime sleepiness as assessed by the Cleveland Adolescent Sleepiness Questionnaire (CASQ) The CASQ is a tool developed to assess daytime sleepiness among adolescents aged 11-17 years old. The questionnaire is a self-reported tool comprised of 16 questions with responses ranging from "Never (0 times per month)" to "Almost every day (5 or more times per week)" and respondents are instructed to indicate their response that best represents how often it applies to them . Higher scores represent greater sleepiness.
Time frame: 56 days
Change in sleep-related hormones from baseline
The difference in change from baseline at Days 28 and 56 between Probiotic and Placebo in sleep-related hormones as assessed by morning salivary cortisol, and nighttime salivary melatonin
Time frame: 56 days
Change in stress-related hormones from baseline
The difference in change from baseline at Days 28 and 56 between Probiotic and Placebo in stress-related hormone as assessed by urinary free cortisol
Time frame: 56 days
Change in mood from baseline
The difference in change from baseline at Days 28 and 56 between Probiotic and Placebo in mood as assessed by the Profile of Mood States 2nd Edition for youth (POMS2-Y) The POMS2-Y is a validated self-reported questionnaire used to measure mood state in youth 13 to 17. The short form questionnaire consists of 35 items to measure "Anger-Hostility", "Confusion-Bewilderment", "Depression-Dejection", "Tension-Anxiety", "Vigor-Activity", "Friendliness" and "Fatigue-Inertia".
Time frame: 56 days
Change in psychological wellbeing from baseline
The difference in change from baseline at Days 28 and 56 between Probiotic and Placebo in psychological wellbeing as assessed by the Youth Anxiety Measure for DSM-5 (YAM-5). The YAM-5 is a validated tool used to measure anxiety symptoms in children and adolescents aged 8 to 18 years based on the Diagnostic and Statistical Manual of Mental Disorders (28, 29). Respondents will be instructed to respond to each item using a four-point scale including 0=never, 1=sometimes, 2=often, and 3=always.
Time frame: 56 days
Change in gastrointestinal symptoms from baseline
The difference in change from baseline at Days 28 and 56 between Probiotic and Placebo in gastrointestinal symptoms as assessed by the modified Gastrointestinal Symptoms Rating Scale (GSRS). The GSRS contains 15 items, each rated on a four-point Likert scale with indications of no discomfort to very severe discomfort. The 15 item GSRS breaks down into 5 scales: abdominal pain, reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (loose stool and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation, and increased flatus), and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The modified GSRS has been revised to improve participant understanding and includes 14 questions with a 4-point instead of a 7-point scale for response options.
Time frame: 56 days
Probiotic strain retrieval in stool samples at 28 and 56 days
DNA will be extracted from stool samples and real time PCR (qPCR) will be conducted to identify the presence of the probiotic strains in participants' stool samples.
Time frame: 56 days
Microbiome composition in stool samples
Stool microbiome composition will be determined by Metagenomics analysis using shotgun metagenomic performed on samples collected at Day 28 and 56. This is explored as a secondary outcome to determine the probiotic effects on the gut microbiome composition and host-microbiome interaction. Moreover, these analyses may provide insight into the mechanisms of action of the investigational product.
Time frame: 56 days
Untargeted metabolomic analysis on fecal microbiome
Stool metabolites will be measured by Untargeted Metabolomics analysis performed on samples collected at Day 28 and 56. This is explored as a secondary outcome to determine the probiotic effects on the metabolites identified in stool samples and may provide insight into the potential mechanisms of action of the investigational product.
Time frame: 56 days