ACTRN12613000438752已完成未知
An investigation of the effects of a probiotic supplement on symptoms of depression and related biomarkers: a double-blind randomized placebo controlled trial with open label extension in people with symptoms of moderate to very severe depression.
A/prof. Julia Rucklidge0 个研究点目标入组 80 人开始时间: 2013年4月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.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).
研究者
相似试验
撤回
不适用
Impact of a probiotic supplement on post-quake psychological distress and related biomarkersStressPhysical healthMental Health - Other mental health disordersInflammatory and Immune System - Other inflammatory or immune system disordersDiet and Nutrition - Other diet and nutrition disordersDepressionACTRN12612000647831niversity of Canterbury63
招募中
2 期
Probiotic supplementation in multiple sclerosisMultiple SclerosisIRCT20220713055465N2Tabriz University of Medical Sciences90
终止
不适用
Probiotics for Reduction of Exam Stress in Students StudyStressMental Health - Studies of normal psychology, cognitive function and behaviourACTRN12620000275965The University of Auckland483
已完成
3 期
The effect of probiotics in improving symptoms of anxiety, depression and appetite in HIV positive patientsCondition 1: Human immunodeficiency virus [HIV] disease. Condition 2: depressive disorder. Condition 3: Insomnia.Human immunodeficiency virus [HIV] diseaseMajor depressive disorder, single episodeInsomnia not due to a substance or known physiological conditionF51.0IRCT20190316043072N3Karaj University of Medical Sciences50
招募中
3 期
Investigating the effect of probiotic supplementation on BrucellosisBrucellosisIRCT20240130060856N1Arak University of Medical Sciences100