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The Effects of Probiotic Supplementation on State and Trait Stress, Anxiety, and Depression Symptoms in Stressed Adults | Clinical Trials | Clareo Health

COMPLETEDNA

The Effects of Probiotic Supplementation on State and Trait Stress, Anxiety, and Depression Symptoms in Stressed Adults

Evaluating the Effects of Lactobacillus Reuteri DSM 17938 on State and Trait Stress in Stressed Adults

NCT07216729•University of Colorado, Boulder

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled trial is to learn if supplementation with the probiotic Lactobacillus reuteri DSM 17938 can reduce levels of trait and state perceived stress, anxiety, and depressive symptoms compared to a placebo in a population of stressed adults ages 18-45. This study also investigates several evidence-based moderators of treatment effects, evaluates whether the probiotic caused side effects, and evaluates whether effects endured at 1-month post-supplementation.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•age 18 - 45
•scoring 14+ on the perceived stress scale-10 indicating medium stress or higher
•ability to provide informed consent
•willingness not to take probiotic supplements (pills, tablets, oils, etc.) other than the product provided in the clinical study until all study procedures are completed
•own a smartphone and are willing to receive study materials and complete study procedures by text

Exclusion Criteria

•a history of gastrointestinal discomfort or surgery, urinary incontinence, cancer, toxic shock syndrome, frequent diarrhea, vital signs outside of the acceptable range (i.e., blood pressure \>160/100, oral temperature \>100°F, pulse \>100), heart disease, heart attack, lung/respiratory disease, any pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality (i.e. a medical diagnosis related to lungs, heart, stomach/intestines, liver, or kidneys), HIV, Hepatitis B, Hepatitis C, bipolar disorder, psychosis, or confirmed or suspected immunosuppression or immunodeficiency
•current (past month) alcohol or substance abuse or dependence (score of 2+ on the UNCOPE)
•consistent (e.g., 5x/week or greater) probiotic supplementation within the last month, including probiotic food products such as yogurt
•receiving antibiotics within the last month
•receiving medications that interfere with gut motility (opiates, loperamide, stool softeners)
•use of systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral)
•use of oral, intravenous, intramuscular, nasal or inhaled corticosteroids
•use of cytokines or cytokine inhibitors
•use of methotrexate or immunosuppressive cytotoxic agents
•receiving immunosuppressive drugs/medications or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy
+4 more criteria

Locations (1)

University of Colorado Boulder, Muenzinger Psychology Building

Boulder, Colorado, United States

Key Dates

Start Date

February 20, 2023

Primary Completion Date

May 6, 2024

Completion Date

June 1, 2024

Last Updated

November 18, 2025

Enrollment

150

ACTUAL participants

Conditions

Anxiety SymptomsPerceived StressDepressive Symptoms

Interventions

Lactobacillus reuteri DSM 17938

DIETARY_SUPPLEMENT

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effects of Probiotic Supplementation on State and Trait Stress, Anxiety, and Depression Symptoms in Stressed Adults

Inclusion Criteria

Exclusion Criteria

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

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