None listed
Conditions
Brief summary
The primary purpose is to develop our published pilot work. This study will evaluate the efficacy of a combined supplement combining orotate and probiotics using a placebo controlled randomsied treatment trial for the treatment of depression. The study hypotheses relate to: 1. participants taking the active supplement will have significantly reduced symptom scores compared with the placebo group. (psychiatric assessments). 2. participants taking the active supplement will have reduced dysbiosis and blood inflammatory markers compared with the placebo group. Changes in dysbiosis will be assessed by fecal testing and changes in systemic inflammatory markers will be assessed by by blood tests.
Interventions
Randomised two group placebo controlled treatment trial of a probiotic - mg orotate formula designed as a treatment for depression. Active condition participants will be administered four capsules daily of a probiotic formula for the entire study duration which are a combination of (20 bill CFU / day for 8 weeks duration along with magnesium orotate (1600 mg / day) or placebo taken as divided into both morning and evening doses. Participants can decide weather they take them with or without a me
Randomised two group placebo controlled treatment trial of a probiotic - mg orotate formula designed as a treatment for depression. Active condition participants will be administered four capsules daily of a probiotic formula for the entire study duration which are a combination of (20 bill CFU / day for 8 weeks duration along with magnesium orotate (1600 mg / day) or placebo taken as divided into both morning and evening doses. Participants can decide weather they take them with or without a meal. The probiotic strains to be tested are Lactobacillus acidophilus, Bifidobacterium bifidum, and Streptococcus thermophiles. Each capsule contains 5 billion CFU of probiotic bacteria as well as 25.5mg magnesium salts attached to 400mg of orotate. Adherence to the dosage schedule will be monitored by participant completed dosage logs and research assistant follow up to monitor conformity to the protocol. The product to be tested has the commercial name NRGBiotic and is developed and supplied by Medlab Australia.
Sponsors
Medlab Clinical LTD
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 meeting all of the following inclusion criteria will be included in the study: Given that there is personality and mood factors that are involved with the assessment and treatment of depression, comprehensive assessment and management criteria has been developed to ensure a representative sample and participant safety. Inclusion criteria: • Participants are diagnosed with depression by a health practitioner. • Participants have not changed the standard care that they are receiving without consulting a primary care physician regardless of clinical improvement during the study. • Participants that present with a high degree of comorbidity on Axis I, II, III (ICD-DSM criterion) will be accepted into the study, given that complex mood, personality and health problems are common in patients diagnosed with depression. • Eligible participants will be 18 years of age with no upper age limit. • Participants will be asked not to be currently administering any nutritional supplements or any herbal medicines that have been shown to have antidepressant effects (a list will be provided to participants). • Participants will be advised not to “self-medicate” with probiotic supplements or any prebiotic supplements for the duration of the trial.
Exclusion criteria
• Participants will not have been diagnosed with major depression as the primary condition. • Participants diagnosed with co-morbid schizophrenia, depression as part of bipolar, or current substance misuse will not be eligible. • Participants with current high suicide risk will not be eligible. • Participants prescribed any form of antibiotics, currently or during previous 4 weeks may be considered for inclusion (if last 4 weeks, wait for entry). • Patients currently administering Warfarin will not be eligible. • Participants who are pregnant or planning pregnancy over 16 weeks will not be eligible. • Serious physical illness (e.g., serious life threatening illness or palliative care) • Participants administering medications other than SSRIs/SNRIs, or, SSRIs/SNRIs in conjunction with other antidepressants will not be eligible. • Participants already taking probiotics under advisement of a health professional will not be eligible. • Participants with an established or suspected obstructive/central sleep apnoea.
Outcome results
None listed