Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- King's College London
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- differences in gut microbiota between MDD and healthy volunteers
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
differences in gut microbiota between MDD and healthy volunteers
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
- Neurotransmitters(change from baseline to week 8)
- Blood(change from baseline to week 8)
- Brain activity(change from baseline to week 8)