The Efficacy of a Probiotic Blend on Stress in Moderately Stressed Teens

NCT05766306 | Completed Phase 2

• 1 other identifier: L-024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

probiotics; probiotic; stress; adolescents; teenagers; teens

Outcome Measures

Primary Outcomes (1)

• 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.

  56 days

Secondary Outcomes (11)

• Change in stress at day 28 from baseline

  28 days

• Change in sleep quality from baseline

  56 days

• Change in daytime sleepiness from baseline

  56 days

• Change in sleep-related hormones from baseline

  56 days

• Change in stress-related hormones from baseline

  56 days

Other Outcomes (3)

• Adverse events

  63 days

• Clinically relevant vital signs - blood pressure

  56 days

• Clinically relevant vital signs - heart rate

  56 days

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants will be randomized to receive the probiotic blend for 56 days.

Dietary Supplement: Probiotic Blend

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive the placebo for 56 days

Dietary Supplement: Placebo

Interventions

Probiotic Blend DIETARY_SUPPLEMENT

Participants will be taking 1 sachet a day, 3 billion CFU.

Probiotic

Placebo DIETARY_SUPPLEMENT

Participants will be taking 1 sachet a day.

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B 3L1, Canada

Location

Study Officials

• Erin Lewis, Ph.D.

  KGK Science Inc.

  STUDY DIRECTOR

• David Crowley, M.D

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blinded.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 13, 2023
• Study Start: March 15, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: February 22, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)