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

NCT03237078 | Unknown

• 1 other identifier: N201702049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Major Depressive Disorder; Inflammation; Probiotics

Keywords

probiotics; major depressive disorder; gut-brain axis; inflammation

Outcome Measures

Primary Outcomes (4)

• Changes of serum hs-CRP

  measure serum hs-CRP at baseline, week 4 and week8

  baseline, week 4 and week 8

• Changes of serum TNF-alpha

  measure serum TNF-alpha at baseline, week 4 and week8

  baseline, week 4 and week 8

• Changes of serum IL-6

  measure serum IL-6 at baseline, week 4 and week8

  baseline, week 4 and week 8

• Changes of serum IL-10

  measure serum IL-10 at baseline, week 4 and week8

  baseline, week 4 and week 8

Secondary Outcomes (6)

• Changes of HAMD-17

  baseline, week 2, week 4 and week 8

• Changes of DSSS

  baseline, week 2, week 4 and week 8

• Change of Microbiota

  baseline and week 8

• Change of zonulin

  baseline and week 8

• Change of calprotectin

  baseline and week 8

Study Arms (1)

Lactobacillus plantarum PS128

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus plantarum PS128

Interventions

Lactobacillus plantarum PS128 DIETARY_SUPPLEMENT

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

Lactobacillus plantarum PS128

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Inflammation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chun-Hsin Chen

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hsin Chen

CONTACT

86-2-29307930; chunhsin57@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2019
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)