None listed
Conditions
Brief summary
The purpose of this study is to evaluate the effect of a probiotic supplement on the treatment of psychological symptoms, such as stress, anxiety and depression, associated with the earthquake experience and its negative consequences on quality of life. Seismic events can cause serious problems of adaptation and lead to significant changes which can affect the daily management of your life. If these situations persist, they can promote an increase in the level of important biological indicators (biomarkers) that regulate your stress response, with consequent harmful effects on your health. Recent studies have demonstrated that the gut is able to communicate with the brain and that the consumption of beneficial gut bacteria can improve psychological symptoms and reduce the level of some relevant biomarkers. The aim of this research is to assess the therapeutic role of a specific probiotic formula in treating these stress-related symptoms.
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 called Probio'Stick and containing two bacterial strains: Lactobacillus Helveticus R0052 and Bifidobacterium longum R0175 (3 x 109 colony-forming units/stick). More detailed information about the product can be found on the manufacturer's website, www.institut-rosell-lallemand.com. Particip
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 called Probio'Stick and containing two bacterial strains: Lactobacillus Helveticus R0052 and Bifidobacterium longum R0175 (3 x 109 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 a day for a period of 8 weeks. The stick is in the form of orodispersible powder and can be taken also without water. Following the RCT, participants enter an open-label trial for a further 8 week period with the same dose of Probio'stick.
Sponsors
University of Canterbury
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants are older than 16 years of age. 2. 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. 3. Participants meet at least one score above the cut-offs of the Depression Anxiety and Stress scale(DASS; Lovibond & Lovibond, 1995). 4. Participants must have been in Christchurch at the time of the one of the major earthquake (September 4th 2010; February 22nd 2011; June 13th 2011; Dec 23rd 2011). 5. Participants are free of psychotropic medication for the trial. 6. Participants who have not recently, within the last 4 days, suffered illness or have signs of inflammation.
Exclusion criteria
1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). 2. Renal, hepatic, cardiovascular and respiratory diseases. 3. Any serious medical condition for which major medical interventions are anticipated during the duration of the trial. 4. Any patient known to have food allergy or to be allergic to the ingredients of the intervention. 5. Pregnancy or breastfeeding 6. Evidence of substance dependence within the previous month. 7. 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. 8. 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. 9. Any type of nutritional or herbal supplement (ginger, guarana, ginseng, dehydroepiandrosterone, melatonin, antioxidants, selenium, replacement hormones) known to have a centrally-acting effect, will result in a patient’s exclusion. 10. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers. 11. 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.
Outcome results
None listed