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Lactobacillus Plantarum PS128 in Patients With Major Depressive Disorder and High Level of Inflammation

NCT03237078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-02

No results posted yet for this study

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 anxiety-like behavior, brain neurochemistry and inflammation. In human studies, the composition of gut microbiota is different between patients with MDD and healthy controls. In addition, supplementation of probiotics can improve mood status in community and clinical participants. Inflammation is one of possible pathway to connect gut and brain. Gut permeability and inflammation level are higher in patients with MDD. Lactobacillus plantarum PS128 in one of bacteria extracted from traditional fermented food, Fu-Tsai. It can alleviate depressive-like behavior reduce inflammation level in maternal separation mice. This study is an 8-week open trial to investigate the effects of Lactobacillus plantarum PS128 on psychophysiology in patients with MDD and higher level of inflammation.

This is a two-phase study. In the first phase, we will recruited patients fulfilling the following inclusion criteria: 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. The exclusion criteria are: 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 state to have dietary pattern changed or in diet within previous two months. Those hs-CRP \> 3 mg/L in the first screen will be invited into the second phase intervention. In the second phase intervention, we will give eligible patients Lactobacillus plantarum PS128 for 8 weeks, and compare depression symptoms, gut microbiota, gut inflammation and permeability, and serum inflammation level before and after intervention.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus plantarum PS128

Each PS 128 capsule contains 300 mg of probiotics. PS128 will be provided 300 mg twice, in the morning and in the afternoon, daily.

Sponsors & Collaborators

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Chun-Hsin Chen · Taipei Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-07-31
Completion
2019-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237078 on ClinicalTrials.gov