Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-28 @ 7:27 PM
Study NCT ID:
NCT05766306
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2023-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of a Probiotic Blend on Stress in Moderately Stressed Teens
Sponsor:
Lallemand Health Solutions
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEEN
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: