Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms

Study Overview
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Brief Summary
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This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12 weeks. At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep questionnaires and blood samples will be collected for biomarker assessments. Fecal samples will be collected prior to the baseline and end-of-study visits for microbial profiling.

Detailed Description
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This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial. Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3 groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG and Bifidobacterium BB-12 or (3) a placebo for 12 weeks. At screening (Visit 1), the study design will be explained to participants, following which signed GDPR and study informed consent will be obtained. Participants will be assessed for eligibility, medical history and concomitant therapies. At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep questionnaires and blood samples will be collected for biomarker assessments. Fecal samples will be collected prior to the baseline and end-of-study visits for microbial profiling.

Official Title
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Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms: A Pilot Randomized Placebo-controlled Trial

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Dietary Supplement: B. adolescentis Bif-038
* Dietary Supplement: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy adults (male and female) 18 to 65 years Currently experiencing depressive symptoms as indicated by a score of between 20 and 40 on the BDI-II at both the screening and baseline visit Body mass index (BMI) between 18.5 and 30.0 kg/m2 Non-smoker No plan to change dietary or exercise habits during the study period No recent history (within 3 months) or plan to commence new treatments over the study period Willing and able to take probiotic/placebo regimen for 12 weeks Understand, willing and able to comply with all study procedures Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial. Exclusion Criteria: Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy Diagnosis of psychiatric or neurological conditions including but not limited to: psychiatric disorders other than mild-to-moderate depression and/or anxiety disorder, or neurological disease (e.g., Parkinson's, Alzheimer's disease, intracranial hemorrhage, head or brain injury) Regular medication intake, including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, benzodiazepines, antipsychotics, opioids, or corticosteroids. Within 2 months before screening, the use of pharmaceutical medications, including but not limited to immunosuppressant drugs, antibiotics, and steroids Change in medication (dose or type) in the last 3 months or an expectation to change during the study duration. Permitted medications include, but are not limited to, pharmaceutical antidepressants such as selective serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs), cholesterol-lowering medications, antihypertensives, proton pump inhibitors, and thyroid medications, Use of probiotics or mood support supplement up to 4 weeks before study commencement Current or 12-month history of illicit drug abuse Alcohol intake greater than 14 standard drinks per week Any significant surgeries over the last year Women who are pregnant, breastfeeding or intend to fall pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B. adolescentis Bif-038<br>Probiotic capsule (single strain) | Dietary Supplement: B. adolescentis Bif-038<br>* B. adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day<br>|
| Experimental: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®<br>Probiotic capsule (combination strain) | Dietary Supplement: Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®<br>* Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day<br>|
| Placebo Comparator: Placebo<br>Placebo capsule | Dietary Supplement: Placebo<br>* Placebo capsule delivered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II (BDI-II) score | Change in BDI-II score after 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory (BAI) score | Change in BAI score | 12 weeks | 
| Depression, Anxiety, Stress Scale (DASS-21) total score | Change in DASS-21 total score | 12 weeks | 
| DASS-21 Stress score | Change in DASS-21 Stress score | 12 weeks | 
| DASS-21 Depression score | Change in DASS-21 Depression score | 12 weeks | 
| DASS-21 Anxiety score | Change in DASS-21 Anxiety score | 12 weeks | 
| Brain-derived neurotrophic factor blood concentration | Change in brain-derived neurotrophic factor blood concentration | 12 weeks |