None listed
Conditions
Brief summary
Whilst CBT has been validated as an effective psychological treatment for depression, efficacy rates of treatment still indicate the need for improvement. Emerging evidence indicates that the relationship between the gut and the brain can be harnessed, so that changes in gastrointestinal health can have positive or negative effects on mental health, and vice versa. This trial investigates whether administration of a probiotic is effective in reducing levels of depression in a population of depressed adults. Participants will consume the probiotic daily, and provide measures of mood throughout the study period. We will measure baseline and post-intervention levels of depressive symptoms, and compare changes in levels of depression between a group provided with the probiotic, and a control group given a placebo.
Interventions
The intervention in this trial will be a probiotic supplied by Winclove Probiotics. Participants will be asked to consume 2 x 2g of the probiotic daily over the course of 8 weeks by dissolving the freeze-dried powder in water and drinking it, and provide weekly measures of mood and depression during this period. Pre and post-measures of depressive symptoms will be taken prior to and after the conclusion of the 8 week probiotic period.
The probiotic powder contains the following ingredients: mai
The intervention in this trial will be a probiotic supplied by Winclove Probiotics. Participants will be asked to consume 2 x 2g of the probiotic daily over the course of 8 weeks by dissolving the freeze-dried powder in water and drinking it, and provide weekly measures of mood and depression during this period. Pre and post-measures of depressive symptoms will be taken prior to and after the conclusion of the 8 week probiotic period. The probiotic powder contains the following ingredients: maize starch, maltodextrins, +/- probiotic bacteria (B. bifidum W23, B. lactis W52; L. acidophilus L37; L. brevis W63, L. casei W56; L. salivarius W24; Lc. lactis W19 and W58), minerals, vegetable protein. The number of Colony Forming Units (CFU) is 2.5 x 10^9 CFU/gram. Participant adherence to probiotic consumption will be monitored through asking them to record how many sachets they took each day, as well as returning of both empty and full probiotic sachets to the research team each week.
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed