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The Effects of Probiotics on Depression: Can a Daily Drink of Good Bacteria Improve Mental Wellbeing?

Not Applicable
Completed
Conditions
Depression
Mental Health - Depression
Registration Number
ACTRN12615001081505
Lead Sponsor
niversity of Technology Sydney
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
72
Inclusion Criteria

Participants must be aged 18 years or above, and at screening have a subclinical or clinical diagnosis of Major Depressive Disorder confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I). Participants must be able to travel to UTS (Ultimo) to participate in the study, and must have access to and regularly check a valid email address. Participants must also be willing to complete questionnaires measuring mood, general wellbeing and health, as well as a measure of blood pressure and a stool sample

Exclusion Criteria

Key exclusion criteria: Participants will be excluded from the trial if they meet any of the following restrictions: currently taking antibiotics or probiotic supplements, taken antibiotics within the 2 weeks prior to the start of the trial, diagnosed with HIV/AIDS, cancer, Crohn’s disease or ulcerative colitis, currently undergoing chemotherapy, lactose-intolerant, gluten-intolerant, high-risk alcohol consumption, experiencing severe depressive symptoms, actively suicidal or experiencing severe suicidal ideation, actively self-harming, pregnant or planning to be pregnant within the time-course of this study, diagnosed with Bipolar disorder, a Personality disorder, a psychotic disorder or otherwise experiencing psychosis, receiving any other treatment for mental health issues (including medications such as anti-depressants) or currently participating in another clinical trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of participants with subclinical or clinical diagnosis of Major Depressive Disorder (MDD), on the Mini International Neuropsychiatric Interview (M.I.N.I)[baseline, post-intervention (8 weeks)];mean score on the Beck Depression Inventory – II[baseline, post-intervention (8 weeks)];mean score on the Depression Anxiety Stress Scale-21[weekly, beginning at baseline through to the end of the intervention period (8 weeks)]
Secondary Outcome Measures
NameTimeMethod
mean score on Beck Anxiety Inventory [baseline, post-intervention (8 weeks)];mean score on Cognitive Reactivity Scale[baseline, post-intervention (8 weeks)]
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