Effect of two probiotic formulations on mental health and mood biomarkers in adults with depressive symptoms

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 62

Inclusion Criteria

1.Generally healthy adults (male and female) 18 to 65 years
2.Currently experience mild to moderate depressive symptoms as indicated by a score of between 20 and 40 on the BDI-II at both the screening and baseline visit
3.Body mass index (BMI) between 18.5 and 30.0 kg/m2
4.Non-smoker
5.No plan to change dietary or exercise habits during the study period
6.No recent history (within 3 months) or plan to commence new treatments over the study period
7.Willing and able to take probiotic/placebo regimen for 12 weeks
8.Understand, willing and able to comply with all study procedures
9.Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.

Exclusion Criteria

1.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
2.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)
3.Regular medication intake, including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, benzodiazepines, antipsychotics, opioids, or corticosteroids.
4.Within 2 months before screening, the use of pharmaceutical medications, including but not limited to immunosuppressant drugs, antibiotics, and steroids
5.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,
6.Use of probiotics or mood support supplement up to 4 weeks before study commencement
7.Current or 12-month history of illicit drug abuse
8.Alcohol intake greater than 14 standard drinks per week
9.Any significant surgeries over the last year
10.Women who are pregnant, breastfeeding or intend to fall pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory-II score[ Day 0, week 6, and 12 (primary endpoint) post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method

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