None listed
Conditions
Brief summary
The purpose of this study is to evaluate the effect of a probiotic supplement on the treatment of the psychological symptoms of depression. Developing research in both animals and humans suggests that some potentially beneficial (probiotic) bacteria which are lowered in states of stress and chronic illness may influence depressive symptoms through effects on the microbial gut-brain axis. Most studies conducted on probiotics and psychological symptoms so far have used animal populations, with only a handful of small human studies having been published at the present time. The aim of this research is to strengthen the current field of research through providing a moderately large human study assessing the efficacy of a specific probiotic formula in treating the symptoms of depression. We will also measure IBS symptoms and related blood-based biomarkers in order to consider possible mechanisms of action.
Interventions
Double-blind randomized controlled trial (RCT) comparing a probiotic supplement (Probio'Stick) with a placebo, followed by an open-label extension. The intervention requires the intake of a probiotic formula (Probio'Stick) containing two bacterial strains: Lactobacillus Helveticus R0052 and Bifidobacterium longum R0175 (3 x 10^9 colony-forming units/stick). More detailed information about the product can be found on the manufacturer's website, www.institut-rosell-lallemand.com. Participants cons
Double-blind randomized controlled trial (RCT) comparing a probiotic supplement (Probio'Stick) with a placebo, followed by an open-label extension. The intervention requires the intake of a probiotic formula (Probio'Stick) containing two bacterial strains: Lactobacillus Helveticus R0052 and Bifidobacterium longum R0175 (3 x 10^9 colony-forming units/stick). More detailed information about the product can be found on the manufacturer's website, www.institut-rosell-lallemand.com. Participants consume 1 probiotic stick per day for a period of 8 weeks. The stick is in the form of an orodispersible powder which can be taken without water. Participants will be asked to record any sticks missed, as well as any unusual events in their life, in a study diary. Following the RCT, participants will be invited to enter an open-label trial for a further 8 week period with the same dose of Probio'Stick.
Sponsors
A/prof. Julia Rucklidge
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
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants are older than 16 years of age. Each participant must have a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol. Participants meet at least one score above the cut-off of 11 on the QIDS or 14 on the DASS-42 depression subscale (moderate to very severe depression). Participants are free of antidepressant and other psychiatric medications for at least four weeks prior to the trial. Participants who have not recently, within the last 4 days, suffered illness or have signs of inflammation.
Exclusion criteria
Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). Any serious medical condition for which major medical interventions are anticipated during the duration of the trial. Any patient known to be allergic to the ingredients of the intervention. Pregnancy or breastfeeding. Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial. Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers. Participants will be asked to minimize their intake of colas, tea, coffee, alcohol, cigarettes and illicit drugs. These substances will be monitored as part of the trial. Participants will be excluded if they take the antidepressant herbal supplement, St John’s Wort. Renal, hepatic, cardiovascular and respiratory diseases Participants will be asked to cease their use of any type of nutritional or herbal supplement known to enhance the immune system (e.g. vitamin C, vitamin E, Echinacea) for the duration of the study as these may affect the efficacy of the probiotics. Any person whose immune system is known to be weakened (e.g. by HIV/AIDS, a genetic defect, long-term use of corticosteroids or taking immunosuppressive medications).
Outcome results
None listed