An investigation of the effects of a probiotic supplement on post-quake psychological distress and related biomarkers: a double-blind randomized placebo controlled trial with open label extension in people who were in Christchurch at the time of the one of the major earthquakes

niversity of Canterbury0 个研究点目标入组 63 人开始时间: 2012年6月19日最近更新: 2020年1月13日

适应症

试验速览

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•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.

•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 If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.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.

发起方

niversity of Canterbury