Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- differences in gut microbiota between MDD and healthy volunteers
研究概览
简要总结
Previous research has suggested that probiotics can improve depressive symptoms in patients with Major Depressive Disorder (MDD), particularly when used in addition to antidepressants. The aim of this exploratory pilot study is to improve the investigator's understanding of the mechanisms underlying these effects. This study will assess the effects of an 8-week double-blind placebo-controlled probiotic intervention on the gut microbiome, inflammatory marker levels, brain activity and neurotransmitter levels in patients with MDD and their relationship to changes in mood. This study will also recruit a group of demographically-matched healthy controls for gut microbiome comparison with the MDD group (non-interventional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for MDD participants:
- •aged 18-55;
- •currently in a depressive episode according to DSM-5 criteria, who are currently on antidepressant treatment but remain symptomatic (HAM-D17 score >13);
- •on stable treatment regimen of an approved treatment for at least 6 weeks;
- •non-smokers;
- •for participants willing to take part in the neuroimaging component: right-handed, no contraindications, non-claustrophobic, weight <126kg;
排除标准
- •for MDD participants:
- •eating disorder, bipolar disorder, schizophrenia or psychotic symptoms;
- •substance dependence in the past year, except for caffeine;
- •active suicidal ideation;
- •use of probiotic supplements in the past 2 weeks, or regular use of a probiotic;
- •use of antibiotics in the past 12 weeks;
- •history of allergic reaction to any of the components of BioKult;
- •history of history of a systemic medical illness;
- •current presence of significant GI problems or disease or history of major GI surgery;
- •pregnancy or breastfeeding;
- •following a dietary regimen unrepresentative of the general population (e.g. fasting or following a specific diet);
- •regular/current use of antacids, proton pump inhibitors, laxatives, antidiarrheals;
- •Inclusion criteria for Healthy Volunteers:
- •Aged 18-55;
- •No current or historic presence of depression, other psychiatric disorder or substance dependence
- •No history of a systemic medical illness;
- •No family history of psychiatric disorder;
- •Non-smoker;
- •Not used probiotic supplements in the past 2 weeks, nor regular use of a probiotic;
- •Not used antibiotics in the past 12 weeks;
- •No current presence of gastrointestinal disease, or history of major GI surgery;
- •No reported regular/current use of antacids, proton pump inhibitors, laxatives, antidiarrheals;
- •pregnancy or breastfeeding;
- •not currently following a dietary regimen or dietary restrictions unrepresentative of the general population (e.g. fasting or following a specific diet);
研究组 & 干预措施
Multi-strain probiotic "BioKult"
4 capsules daily for 8 weeks
干预措施: Multi-strain probiotic (Dietary Supplement)
Placebo
4 capsules daily for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
differences in gut microbiota between MDD and healthy volunteers
时间窗: baseline
species diversity and abundance at the level of OTUs will be measured with 16SrRNA-based sequencing and compared between the two groups
gut microbiota in MDD
时间窗: baseline
species diversity and abundance at the level of organisational taxonomic units (OTUs) will be measured with 16S ribosomal RNA (rRNA) sequencing
gut microbiota changes in MDD following probiotic intervention and their correlation to change in depressive symptoms
时间窗: change from baseline to week 8
species diversity and abundance at the level of OTUs will be measured with 16SrRNA-based sequencing and depressive symptoms will be measured with the Inventory of Depressive Symptomatology Self-Report (IDS-SR) and the Hamilton Depression Rating Scale (HAM-D17)
次要结局
- Neurotransmitters(change from baseline to week 8)
- Blood(change from baseline to week 8)
- Brain activity(change from baseline to week 8)