Clinical trial NCT05766306: The Efficacy of a Probiotic Blend on Stress in Moderately Stressed Teens
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Keywords: probiotics
probiotic
stress
adolescents
teenagers
teens
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2023-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blinded.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Males and females between 13 and 17 years, inclusive
2. 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
   * 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
3. Enrolled in and currently attending school at baseline and for the duration of the study period
4. Individuals with moderate stress as determined by a score of 14-26 on the PSS
5. Does not have an anxiety disorder as determined by QI assessment of the YAM-5
6. Can fluently read and speak English
7. 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
8. 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)
9. Willingness and ability to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
10. Willingness to provide biological samples (saliva, urine, stool) three times during the study
11. 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
12. Healthy as determined by medical history as assessed by Q

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
3. 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
4. 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
5. Previous diagnosis of neurological diseases (e.g., epilepsy, muscular dystrophy, cerebral palsy) assessed by the QI
6. Currently suffering from periodontitis as assessed by the QI
7. 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
8. 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
9. Individuals with an autoimmune disease or are immune compromised
10. Use of medical cannabinoid products as assessed by the QI
11. Use of cannabinoid, tobacco or nicotine-containing products, or alcohol consumption
12. Alcohol or drug abuse within the last 12 months
13. 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.
14. Current use of prescribed medications that may affect stress, sleep and/or mood
15. Current use of antibiotics. The participant may be eligible after a 30-day washout period prior to their baseline visit
16. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
17. Individuals who are cognitively impaired and/or unable to give informed consent
18. 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

Primary outcomes:
measure: Change in stress at day 56 from baseline
timeFrame: 56 days
Secondary outcomes:
measure: Change in stress at day 28 from baseline
timeFrame: 28 days
measure: Change in sleep quality from baseline
timeFrame: 56 days
measure: Change in daytime sleepiness from baseline
timeFrame: 56 days
measure: Change in sleep-related hormones from baseline
timeFrame: 56 days
measure: Change in stress-related hormones from baseline
timeFrame: 56 days
measure: Change in mood from baseline
timeFrame: 56 days
measure: Change in psychological wellbeing from baseline
timeFrame: 56 days
measure: Change in gastrointestinal symptoms from baseline
timeFrame: 56 days
measure: Probiotic strain retrieval in stool samples at 28 and 56 days
timeFrame: 56 days
measure: Microbiome composition in stool samples
timeFrame: 56 days
measure: Untargeted metabolomic analysis on fecal microbiome
timeFrame: 56 days
Other outcomes:
measure: Adverse events
timeFrame: 63 days
measure: Clinically relevant vital signs - blood pressure
timeFrame: 56 days
measure: Clinically relevant vital signs - heart rate
timeFrame: 56 days
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Erin Lewis, Ph.D.
role: STUDY_DIRECTOR
affiliation: KGK Science Inc.
name: David Crowley, M.D
role: PRINCIPAL_INVESTIGATOR
References: