StressPhase 2TEENNCT05766306
The Efficacy of a Probiotic Blend on Stress in Moderately Stressed Teens
A Phase 2 study testing Probiotic Blend in people with Stress, run by Lallemand Health Solutions at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Probiotic Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2023to 2 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males and females between 13 and 17 years, inclusive
- Individuals of child-bearing potential must have a negative screening urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Abstinence or agrees to use contraception if planning to become sexually active
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
Show all 18Show fewer
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Enrolled in and currently attending school at baseline and for the duration of the study period
- Individuals with moderate stress as determined by a score of 14-26 on the PSS
- Does not have an anxiety disorder as determined by QI assessment of the YAM-5
- Can fluently read and speak English
- Willing to discontinue consumption of probiotic supplements, probiotic fortified products (e.g., fortified yogurt) and fiber supplements (e.g., Metamucil, Benefiber) for the corresponding washout period indicated in Section 7.3.2 and throughout the study
- Willingness to maintain current lifestyle habits as much as possible throughout the study including diet, exercise, sleep, and non-pharmacological therapies (e.g., meditation, yoga, breathing exercises)
- Willingness and ability to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
- Willingness to provide biological samples (saliva, urine, stool) three times during the study
- The child and the child's parent(s) or legal guardian(s) to provide voluntary, written, informed assent and consent, respectively, for their child to participate in the study
- Healthy as determined by medical history as assessed by Q
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- Previous diagnosis or treatment of a mental health disorder or neurodevelopmental disorder, including anxiety disorders (e.g., generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, seasonal affective disorder), mood disorders (e.g., major depressive disorder, bipolar disorder) or attention deficit/hyperactivity disorder within the last two years as assessed by the QI
- Current diagnosis of a sleep disorder (e.g., obstructive sleep apnea, sleep terrors, parasomnia, restless leg syndrome), or a disorder which requires medication that may affect sleep as assessed by the QI
- Previous diagnosis of neurological diseases (e.g., epilepsy, muscular dystrophy, cerebral palsy) assessed by the QI
- Currently suffering from periodontitis as assessed by the QI
Show all 18Show fewer
- Travelled across 1 or more time zones in the last 3 weeks prior to baseline and/or is anticipating more travel during the study period
- Current or history of any significant diseases of the gastrointestinal tract (e.g., Crohn's disease, ulcerative colitis, peptic ulcer disease) as assessed by the QI
- Individuals with an autoimmune disease or are immune compromised
- Use of medical cannabinoid products as assessed by the QI
- Use of cannabinoid, tobacco or nicotine-containing products, or alcohol consumption
- Alcohol or drug abuse within the last 12 months
- Regular consumption of over-the-counter medications, supplements (e.g., melatonin), foods or drinks that may affect stress or sleep. The participant may be eligible after a washout period prior to their baseline visit and if they agree to discontinue use of the product throughout the study.
- Current use of prescribed medications that may affect stress, sleep and/or mood
- Current use of antibiotics. The participant may be eligible after a 30-day washout period prior to their baseline visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are cognitively impaired and/or unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study Investigating the Efficacy of a Probiotic Blend on Stress in Adolescents With Moderate Perceived Stress
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.
Read the detailed description
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.
- Conditions
- Stress
- Being tested
- Probiotic Blend, Placebo
- Keywords
- probiotics, probiotic, stress, adolescents, teenagers, teens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic BlendDietary supplement
Participants will be taking 1 sachet a day, 3 billion CFU.
PlaceboDietary supplement
Participants will be taking 1 sachet a day.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will be randomized to receive the probiotic blend for 56 days. Receives: Dietary Supplement: Probiotic Blend |
| Placebo | Placebo comparator | Participants will be randomized to receive the placebo for 56 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 56 days
Change in daytime sleepiness from baseline
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.
Measured: 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
Measured: 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
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Mar 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blinded.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Erin Lewis, Ph.D., Study director, KGK Science Inc.David Crowley, M.D, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766306
- Sponsor's protocol ID
- L-024
- Acronym
- TEEN
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study Investigating the Efficacy of a Probiotic Blend on Stress in Adolescents With Moderate Perceived Stress
- ClinicalTrials.gov ID
- NCT05766306
- Acronym / sponsor ID
- TEEN / L-024
- Conditions
- Stress
- Keywords
- probiotics, probiotic, stress, adolescents, teenagers, teens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blinded.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic BlendParticipants will be randomized to receive the probiotic blend for 56 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will be randomized to receive the placebo for 56 days |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Males and females between 13 and 17 years, inclusive
- Individuals of child-bearing potential must have a negative screening urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Enrolled in and currently attending school at baseline and for the duration of the study period
- Individuals with moderate stress as determined by a score of 14-26 on the PSS
- Does not have an anxiety disorder as determined by QI assessment of the YAM-5
Key exclusion criteria (18 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- Previous diagnosis or treatment of a mental health disorder or neurodevelopmental disorder, including anxiety disorders (e.g., generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, seasonal affective disorder), mood disorders (e.g., major depressive disorder, bipolar disorder) or attention deficit/hyperactivity disorder within the last two years as assessed by the QI
- Current diagnosis of a sleep disorder (e.g., obstructive sleep apnea, sleep terrors, parasomnia, restless leg syndrome), or a disorder which requires medication that may affect sleep as assessed by the QI
- Previous diagnosis of neurological diseases (e.g., epilepsy, muscular dystrophy, cerebral palsy) assessed by the QI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic BlendParticipants will be taking 1 sachet a day, 3 billion CFU. | Dietary supplement | Probiotic |
| PlaceboParticipants will be taking 1 sachet a day. | Dietary supplement | Placebo |
Primary outcome
Change in stress at day 56 from baseline
Time frame: 56 days
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.
11 secondary outcomes
Change in stress at day 28 from baseline
Time frame: 28 days
Change in sleep quality from baseline
Time frame: 56 days
Change in daytime sleepiness from baseline
Time frame: 56 days
Change in sleep-related hormones from baseline
Time frame: 56 days
Change in stress-related hormones from baseline
Time frame: 56 days
Change in mood from baseline
Time frame: 56 days
Change in psychological wellbeing from baseline
Time frame: 56 days
Change in gastrointestinal symptoms from baseline
Time frame: 56 days
Probiotic strain retrieval in stool samples at 28 and 56 days
Time frame: 56 days
Microbiome composition in stool samples
Time frame: 56 days
Untargeted metabolomic analysis on fecal microbiome
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No. After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Lewis, Ph.D. study director
KGK Science Inc.
David Crowley, M.D principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic Blend in people with Stress, run by Lallemand Health Solutions at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress at day 56 from baseline (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.