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Probiotic Blend for Teen Stress (TEEN Trial)
Phase 2
Waitlist Available
Led By David Crowley, M.D
Research Sponsored by Lallemand Health Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 days
Awards & highlights
TEEN Trial Summary
This trial is testing if a probiotic blend can reduce stress in teens with moderate stress levels. Placebos will be given to a control group.
Who is the study for?
This trial is for teens aged 13-17 with moderate stress, not pregnant or planning to become so, and willing to use birth control if sexually active. They must be attending school, speak English fluently, agree to avoid certain products like probiotic supplements during the study, and maintain their lifestyle habits. Teens with mental health disorders or significant medical conditions are excluded.Check my eligibility
What is being tested?
The study aims to see if a special blend of probiotics can help reduce stress in moderately stressed teenagers compared to a placebo. Participants will either receive the probiotic blend or a placebo and their stress levels will be monitored to determine any differences between the two groups.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, common side effects from taking probiotics may include digestive discomfort such as gas or bloating. Since it's a natural supplement being tested against a placebo, severe side effects are unlikely.
TEEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 63 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~63 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in stress at day 56 from baseline
Secondary outcome measures
Change in daytime sleepiness from baseline
Change in gastrointestinal symptoms from baseline
Change in mood from baseline
+8 moreOther outcome measures
Adverse events
Clinically relevant vital signs - blood pressure
Clinically relevant vital signs - heart rate
TEEN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
Participants will be randomized to receive the probiotic blend for 56 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive the placebo for 56 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic Blend
2023
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,130 Total Patients Enrolled
Lallemand Health SolutionsLead Sponsor
39 Previous Clinical Trials
3,689 Total Patients Enrolled
Erin Lewis, Ph.D.Study DirectorKGK Science Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be 18 or older, able to understand and communicate fluently in English, have no child-bearing potential or agree to use a medically approved method of birth control for the duration of the study, have moderate stress (SCARED Score <25) and not take probiotic supplements, fiber supplements, maintain their current lifestyle habits including diet/exercise/sleep etc., complete questionnaires & records associated with the study as well as all clinic visits, provide biological samples 3 times during the study period and lastly consent from parent(s) / legal guardian(s).
Research Study Groups:
This trial has the following groups:- Group 1: Probiotic
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range of this trial limited to those under 55 years old?
"As per the requirements for involvement in this trial, adolescent patients between ages 13 and 17 are eligible to take part."
Answered by AI
Has Probiotic acquired the necessary regulatory approval to be sold commercially?
"Probiotic has been deemed a Level 2 risk due to pre-existing data attesting to its safety but an absence of evidence for efficacy."
Answered by AI
Are researchers currently seeking participants for this clinical trial?
"Reportedly, this clinical trial is not currently recruiting participants. The study was first uploaded on May 1st 2023 and has been edited most recently March 2nd 2023; however, there are 143 other trials that are actively seeking candidates."
Answered by AI
Do I meet the requirements to participate in this clinical research?
"Eligibility criteria for this clinical trial requires that participants are adolescent and suffer from stress. 30 individuals between the ages of 13 and 17 will be recruited in total."
Answered by AI
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