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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
150
5 drops (100 million CFUs) daily for 46 days of L. reuteri DSM 17938 in sunflower oil, medium chain triglyceride oil, and silicon dioxide.
5 drops daily for 46 days of placebo consisting of inactive ingredients from probiotic supplement, specifically sunflower oil, medium chain triglyceride oil, and silicon dioxide.
University of Colorado Boulder, Muenzinger Psychology Building
Boulder, Colorado, United States
Change from baseline in mean trait perceived stress as assessed by PSS-10
Perceived stress scale-10 (PSS-10) administered via REDCap. Possible score range of 0 to 40, with 0-13 considered low stress, 14-26 moderate stress, and 27-40 high stress.
Time frame: Baseline and the end of treatment at 46 days
State perceived stress as assessed by adapted PSS-4 using ecological momentary assessment
Perceived stress scale-4 (PSS-4) administered via REDCap and adapted for state measurement. The investigators adapted this measure for state stress by asking participants to rate the intensity of perceived stress they were experiencing in the moment, as opposed to the frequency with which they experienced perceived stress over the past month. Possible score range of 0 to 16, with higher scores indicating higher levels of state stress.
Time frame: Five times per day (hourly, 12-7pm, sent via text with a 15 minute response window) during the last 5 days of supplementation, days 42 to 46, when the investigators expect participants to have reached maximum benefit
Change from baseline in mean trait anxiety symptoms as assessed by GAD-7
Generalized Anxiety Disorder-7 scale (GAD-7) administered via REDCap. Possible score range of 0 to 21, with higher scores indicating higher levels of anxiety symptoms.
Time frame: Baseline and the end of treatment at 46 days
State anxiety symptoms as assessed with the SUDS using ecological momentary assessment
Subjective units of distress scale (SUDS) administered via REDCap. Possible score range of 0 to 100, with higher scores indicating higher levels of state anxiety.
Time frame: Five times per day (hourly, 12-7pm, sent via text with a 15 minute response window) during the last 5 days of supplementation, days 42 to 46, when the investigators expect participants to have reached maximum benefit
Change from baseline in mean trait depressive symptoms as assessed by the PHQ-8
Patient Health Questionnaire-8 (PHQ-8) administered via REDCap. Possible score range of 0 to 24, with higher scores indicating higher levels of depression.
Time frame: Baseline and the end of treatment at 46 days
State depressive symptoms as assessed by SUDS using ecological momentary assessment
Subjective Units of Distress Scale (SUDS) administered via REDCap. Possible score range of 0 to 100, with higher scores indicating higher levels of state depression.
Time frame: Five times per day (hourly, 12-7pm, sent via text with a 15 minute response window) during the last 5 days of supplementation, days 42 to 46, when the investigators expect participants to have reached maximum benefit
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