King's College London
London, SE5 8AF, United Kingdom
NCT Number: NCT03893162
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).
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
London, SE5 8AF, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for MDD participants:
Exclusion criteria
for MDD participants:
Inclusion criteria
for Healthy Volunteers:
The intervention in this study is a multi-strain probiotic which contains:
Bacillus subtilis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus delbrueckii ssp. bulgaricus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus salivarius, Lactococcus lactis ssp. lactis, Streptococcus thermophilus.
Each capsule contains minimum 2 billion live microorganisms per capsule, equivalent to 10 billion live microorganisms per gram.
Other names: "BioKult"
Visually identical capsules in identical packaging containing no active bacteria.
Time frame: baseline
species diversity and abundance at the level of organisational taxonomic units (OTUs) will be measured with 16S ribosomal RNA (rRNA) sequencing
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
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)
Time frame: change from baseline to week 8
levels of glutamate and gamma-aminobutyric acid (GABA) will be measured with Magnetic Resonance Imaging (MRS)
Time frame: change from baseline to week 8
levels of tumor necrosis factor (TNF-a), interleukins IL-1β, IL-6, IL-17, and C-reactive protein (CRP) will be measured
Time frame: change from baseline to week 8
measured with functional magnetic resonance imaging (fMRI)
King's College London
Other
Acronym: PROMEX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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