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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 5 drops daily (100 million colony-forming units) for 46 days of Lactobacillus reuteri DSM 17938 in sunflower oil, medium chain triglyceride oil, and silicon dioxide. |
|
| Placebo | Placebo Comparator | 5 drops daily for 46 days of a placebo consisting of the inactive ingredients from the probiotic supplement, specifically sunflower oil, medium chain triglyceride oil, and silicon dioxide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Dietary Supplement | 5 drops (100 million CFUs) daily for 46 days of L. reuteri DSM 17938 in sunflower oil, medium chain triglyceride oil, and silicon dioxide. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and the end of treatment at 46 days |
| State anxiety symptoms as assessed with the SUDS using ecological momentary assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects as assessed on the final day of supplementation using the GASE | Generic Assessment of Side Effects (GASE), excluding the question assessing suicidality and administered on REDCap. This measure assesses 35 of the most common subjective side effects of clinical trials (e.g., nausea), and asks participants to rate whether they experienced each complaint on a scale from 0 ("not present") to 3 ("severe"). If they endorsed experiencing a side effect (score of 1+), participants were then asked whether the complaint related to the probiotic (yes/no). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren B Finkelstein, MA | University of Colorado, Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder, Muenzinger Psychology Building | Boulder | Colorado | 80309 | United States |
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| Label | URL |
|---|---|
| Prior pre-registration on Open Science Framework, initially submitted prior to starting data collection | View source |
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Deidentified individual participant data (IPD) will be shared with other researchers in our lab to conduct secondary analyses. Data sharing will ensure protection of participant confidentiality.
Beginning late summer/early fall of 2024 with no end date
Faculty advisor who oversaw the initial trial is supervising another graduate student to use the data to address research questions outlined in the IRB-approved protocol, in addition to some secondary analyses.
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| Placebo | Other | 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. |
|
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. |
| 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. | 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. | 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 |
| End of treatment at day 46 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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