Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    fermented foods mood
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237078
Recruitment Status : Unknown
Verified June 2018 by Chun-Hsin Chen, Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : August 2, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Chun-Hsin Chen, Taipei Medical University WanFang Hospital

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Inflammation Probiotics Dietary Supplement: Lactobacillus plantarum PS128 Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychophysiological Effects of Lactobacillus Plantarum PS128 in Patients With Major Depressive Disorder and High Level of Inflammation: a Pilot Study of 8-week Open Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Changes of serum hs-CRP [ Time Frame: baseline, week 4 and week 8 ]
    measure serum hs-CRP at baseline, week 4 and week8

  2. Changes of serum TNF-alpha [ Time Frame: baseline, week 4 and week 8 ]
    measure serum TNF-alpha at baseline, week 4 and week8

  3. Changes of serum IL-6 [ Time Frame: baseline, week 4 and week 8 ]
    measure serum IL-6 at baseline, week 4 and week8

  4. Changes of serum IL-10 [ Time Frame: baseline, week 4 and week 8 ]
    measure serum IL-10 at baseline, week 4 and week8


Secondary Outcome Measures :
  1. Changes of HAMD-17 [ Time Frame: baseline, week 2, week 4 and week 8 ]
    measure depression rating at baseline, week 2, week 4 and week 8

  2. Changes of DSSS [ Time Frame: baseline, week 2, week 4 and week 8 ]
    measure depression rating at baseline, week 2, week 4 and week 8

  3. Change of Microbiota [ Time Frame: baseline and week 8 ]
    gut microbiota analyses at baseline and week 8

  4. Change of zonulin [ Time Frame: baseline and week 8 ]
    measure gut permeability at baseline and week 8

  5. Change of calprotectin [ Time Frame: baseline and week 8 ]
    measure gut inflammation at baseline and week 8

  6. Changes of expression of Toll-like proteins [ Time Frame: baseline and week 8 ]
    measure of expression of TLPs at baseline and week 8



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20-65
  2. fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of major depressive episode in recent 2 years
  3. Psychotropics including antidepressants, antipsychotics and hypnotics have been kept unchanged for at least 3 months
  4. hs-CRP > 3 mg/L
  5. HAMD-17 < 14

Exclusion Criteria:

  1. Comorbid with schizophrenia, bipolar disorder, or other substance use (except tobacco) disorder.
  2. having active suicidal or homicidal ideation
  3. known allergy to probiotics
  4. comorbid with hypertension, diabetes mellitus, irritable bowel syndrome, inflammatory bowl disease, liver cirrhosis, or autoimmune diseases
  5. known active bacterial, fungal, or viral infections in one month.
  6. use of antibiotics, steroid, immunosuppressants, probiotics, or synbiotics in the month before collecting blood and fecal samples
  7. pregnant or lactating women
  8. who obviously change dietary pattern or in diet within previous two months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237078


Contacts
Layout table for location contacts
Contact: Chun-Hsin Chen 86-2-29307930 chunhsin57@yahoo.com.tw

Locations
Layout table for location information
Taiwan
Taipei Medical University - WanFang Hospital Recruiting
Taipei, Taiwan
Contact: Chun-Hsin Chen    886-2-29307930 ext 53961    chunhsin57@yahoo.com.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chun-Hsin Chen Taipei Medical University
Layout table for additonal information
Responsible Party: Chun-Hsin Chen, Attending Psychiatrist, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT03237078    
Other Study ID Numbers: N201702049
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chun-Hsin Chen, Taipei Medical University WanFang Hospital:
probiotics
major depressive disorder
gut-brain axis
inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Inflammation
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms