Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics (PROMEX)

This is an interventional basic science trial for Major Depressive Disorder focused on measuring probiotic, depression, microbiome, bacteria Read More

Inclusion criteria 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;

Exclusion criteria 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);