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

NCT ID: NCT05766306

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-02-02

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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

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

Group Type: EXPERIMENTAL

Probiotic Blend

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Participants will be randomized to receive the placebo for 56 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will be taking 1 sachet a day.

Interventions

Probiotic Blend

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will be taking 1 sachet a day.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Lallemand Health Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Lewis, Ph.D.

Role: STUDY_DIRECTOR

KGK Science Inc.

David Crowley, M.D

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

L-024

Identifier Type: -

Identifier Source: org_study_id