Status:
UNKNOWN
Lactobacillus Plantarum PS128 in Patients With Major Depressive Disorder and High Level of Inflammation
Lead Sponsor:
Taipei Medical University WanFang Hospital
Conditions:
Major Depressive Disorder
Inflammation
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
Recent studies have suggested that gut-brain axis may be one of the mechanisms of major depression disorder (MDD). In animal studies, alteration of gut microbiota can affect animal's depression or anx...
Detailed Description
1\. Background Major depressive disorder (MDD) is a complex and long-term illness that involves marked disabilities in affected patients. It has been one of the leading causes of global burden of dise...
Eligibility Criteria
Inclusion
- Age 20-65
- fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of major depressive episode in recent 2 years
- Psychotropics including antidepressants, antipsychotics and hypnotics have been kept unchanged for at least 3 months
- hs-CRP \> 3 mg/L
- HAMD-17 \< 14
Exclusion
- Comorbid with schizophrenia, bipolar disorder, or other substance use (except tobacco) disorder.
- having active suicidal or homicidal ideation
- known allergy to probiotics
- comorbid with hypertension, diabetes mellitus, irritable bowel syndrome, inflammatory bowl disease, liver cirrhosis, or autoimmune diseases
- known active bacterial, fungal, or viral infections in one month.
- use of antibiotics, steroid, immunosuppressants, probiotics, or synbiotics in the month before collecting blood and fecal samples
- pregnant or lactating women
- who obviously change dietary pattern or in diet within previous two months
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03237078
Start Date
August 1 2017
End Date
July 31 2019
Last Update
July 2 2018
Active Locations (1)
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1
Taipei Medical University - WanFang Hospital
Taipei, Taiwan