Clinical trial NCT03893162: Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics
Official title: Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: probiotic
depression
microbiome
bacteria
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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);

Primary outcomes:
measure: gut microbiota in MDD
timeFrame: baseline
measure: differences in gut microbiota between MDD and healthy volunteers
timeFrame: baseline
measure: gut microbiota changes in MDD following probiotic intervention and their correlation to change in depressive symptoms
timeFrame: change from baseline to week 8
Secondary outcomes:
measure: Neurotransmitters
timeFrame: change from baseline to week 8
measure: Blood
timeFrame: change from baseline to week 8
measure: Brain activity
timeFrame: change from baseline to week 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Institute of Psychiatry Psychology and Neuroscience, King's College London
name: James M Stone, MBBS PhD FRCPsych
role: PRINCIPAL_INVESTIGATOR
References: