None listed
Conditions
Brief summary
Depression is a serious health condition that has a considerable negative impact on both physical and mental health. It is one of the leading causes of disease worldwide and represents a huge burden on health care costs. The possible therapeutic impact of dietary changes on mental illness has been receiving increasing attention. Dietary intervention for the treatment of major depressive episodes has shown promise. Some of the many biological pathways by which dietary improvement may influence depressive illness focus on inflammatory and oxidative stress pathways, as well as brain plasticity, while more recently new evidence has focused on the gut microbiota. The intestinal microbiota plays a crucial role in the bidirectional communication between the gut and brain (i.e. the so-called gut-brain axis). Probiotic supplementation can be viewed as a form of controlled dietary intervention that allows modification of the microbial environment. Recent demonstration that probiotic administration has positive effects on depressive feelings in healthy populations (Marotta et al 2019) suggests its possible role in the management for depression in clinical populations and as a non-invasive strategy to prevent depressive feelings in healthy individuals. The present study extends current knowledge on the beneficial effects of probiotics on mood (i.e., depression) and other aspects of psychological well-being, (e.g., anxiety, quality of life) and explores potential mediating factors (e.g., biomarkers of inflammation, stress and changes in the gut microbiome). The research question being addressed is whether 3-months of supplementation with the Biome Lift™ Probiotic can reduce severity of depressive symptoms? For this double-blind, placebo-controlled trial, patients with subthreshold depression will be randomly assigned to an experimental or control group, involving a daily dose of probiotic or placebo, respectively, for 3-months. The findings of this study will contribute to the better understanding of the role that probiotic administration and consequent gut microbiota changes have on the gut-brain axis and their involvement in the etiology of depression and other psychological outcomes.
Interventions
Dietary supplement: Biome Lift probiotic
1 probiotic per day for 3 months taken as an oral tablet, where each probiotic contains 355mg of 4x109 CFU of a mixture of lyophilised probiotic strains of the following species:
• Lactobacillus fermentum
• Lactobacillus rhamnosus
• Lactobacillus plantarum
• Bifidobacterium longum
Adherence will be monitored by tablet return and count of blisters opened on tablet pack, plus tick boxes in dietary diaries.
Sponsors
La Trobe University
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 65 Years
Healthy volunteers
No
Inclusion criteria
• Not in the underweight category (BMI greater than or equal to 18.5 kg/m2); • Meet the criteria for subthreshold depression; • Have not been taking antidepressants or other medications acting on the CNS for at least 6 weeks (all potential participants will be advised to not stop taking any medication prior to consulting their GP);
Exclusion criteria
• Patients with comorbidity with substance use disorders or organic mental disorders; • Patients with neurological conditions affecting the brain or other central functions; • Patients with organic co-morbidities affecting, in particular, the gastrointestinal system, or autoimmune or chronic inflammatory conditions; • Patients who are taking nutritional supplements containing vitamins, minerals or antioxidants in the six weeks before the start of the trial participation; • Patients who have been taking antibiotics in the six weeks before the start of the trial participation; • Patients who are pregnant or are breastfeeding;
Outcome results
None listed