search
Back to results

Effect of Probiotic on Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
China Agricultural University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Normal body mass index ≥ 18.5 until ≤ 29.9
  • Mild to moderate major depression diagnosed by psychiatrists according to the diagnostic criteria for depressive episodes in DSM-5 (American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition))
  • Hamilton Rating Scale for Depression (HAMD-17) score not less than 8
  • Agreed to intake study product during the study period
  • Agreed to sign written informed consent

Exclusion Criteria:

  • Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study
  • Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements
  • Persons with a milk protein allergy, lactose intolerance
  • Pregnant or breastfeeding women
  • Subject had other serious diseases

Sites / Locations

  • Beijing Chinese Medicine Hospital Pinggu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Formula probiotic contains freeze-dried Lactobacillus casei, Bafidobacterium animals, Bifidobacterium longum, Bifidobacterium bidium and Lactobacillus plantarum, each at a dosage of 3.0E+10 CFU per 2g sachet.

Placebo made with only the excipients. The placebo sachet was matched to the study probiotic products for taste, color, and size.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale
Depressive symptoms as measured with the Hamilton Rating Scale for Depression. The score rangs from 0 to 53. The higher score means severer depressive symptoms.

Secondary Outcome Measures

Fecal microbiome
changes in the profile of gut microbiota before and after 8-week intervention.
Serum Il-1β
Serum Il-1β levels before and after intervention assessed by ELISA.
Serum Il-6
Serum Il-6 levels before and after intervention assessed by ELISA.
Serum TNF-α
Serum TNF-α levels before and after intervention assessed by ELISA.
Serum cortisol
Serum cortisol levels before and after intervention assessed by ELISA.
Serum Brain-derived neurotrophic factor
Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA.

Full Information

First Posted
September 20, 2020
Last Updated
September 25, 2020
Sponsor
China Agricultural University
search

1. Study Identification

Unique Protocol Identification Number
NCT04567147
Brief Title
Effect of Probiotic on Depression
Official Title
Effect of Probiotic on Depressive Symptom in Chinese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
June 22, 2019 (Actual)
Study Completion Date
September 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Agricultural University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Depressive disorder, also known as depression, is a type of mood disorder characterized by persistent low mood. The incidence of depression worldwide is about 6%. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animalis, Bifidobacterium longum, Bifidobacterium bifidum and Lactobacillus plantarum) on depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Formula probiotic contains freeze-dried Lactobacillus casei, Bafidobacterium animals, Bifidobacterium longum, Bifidobacterium bidium and Lactobacillus plantarum, each at a dosage of 3.0E+10 CFU per 2g sachet.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo made with only the excipients. The placebo sachet was matched to the study probiotic products for taste, color, and size.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
Depressive symptoms as measured with the Hamilton Rating Scale for Depression. The score rangs from 0 to 53. The higher score means severer depressive symptoms.
Time Frame
Changes in the HAMD score at baseline and 8-week intervention
Secondary Outcome Measure Information:
Title
Fecal microbiome
Description
changes in the profile of gut microbiota before and after 8-week intervention.
Time Frame
Changes between at baseline and 8-week intervention
Title
Serum Il-1β
Description
Serum Il-1β levels before and after intervention assessed by ELISA.
Time Frame
change from baseline to intervention measurements at 8 weeks
Title
Serum Il-6
Description
Serum Il-6 levels before and after intervention assessed by ELISA.
Time Frame
change from baseline to intervention measurements at 8 weeks
Title
Serum TNF-α
Description
Serum TNF-α levels before and after intervention assessed by ELISA.
Time Frame
change from baseline to intervention measurements at 8 weeks
Title
Serum cortisol
Description
Serum cortisol levels before and after intervention assessed by ELISA.
Time Frame
change from baseline to intervention measurements at 8 weeks
Title
Serum Brain-derived neurotrophic factor
Description
Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA.
Time Frame
change from baseline to intervention measurements at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Normal body mass index ≥ 18.5 until ≤ 29.9 Mild to moderate major depression diagnosed by psychiatrists according to the diagnostic criteria for depressive episodes in DSM-5 (American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition)) Hamilton Rating Scale for Depression (HAMD-17) score not less than 8 Agreed to intake study product during the study period Agreed to sign written informed consent Exclusion Criteria: Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements Persons with a milk protein allergy, lactose intolerance Pregnant or breastfeeding women Subject had other serious diseases
Facility Information:
Facility Name
Beijing Chinese Medicine Hospital Pinggu Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21791035
Citation
Bromet E, Andrade LH, Hwang I, Sampson NA, Alonso J, de Girolamo G, de Graaf R, Demyttenaere K, Hu C, Iwata N, Karam AN, Kaur J, Kostyuchenko S, Lepine JP, Levinson D, Matschinger H, Mora ME, Browne MO, Posada-Villa J, Viana MC, Williams DR, Kessler RC. Cross-national epidemiology of DSM-IV major depressive episode. BMC Med. 2011 Jul 26;9:90. doi: 10.1186/1741-7015-9-90.
Results Reference
background
PubMed Identifier
27288567
Citation
Aizawa E, Tsuji H, Asahara T, Takahashi T, Teraishi T, Yoshida S, Ota M, Koga N, Hattori K, Kunugi H. Possible association of Bifidobacterium and Lactobacillus in the gut microbiota of patients with major depressive disorder. J Affect Disord. 2016 Sep 15;202:254-7. doi: 10.1016/j.jad.2016.05.038. Epub 2016 May 24.
Results Reference
result
PubMed Identifier
28239408
Citation
Wallace CJK, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann Gen Psychiatry. 2017 Feb 20;16:14. doi: 10.1186/s12991-017-0138-2. eCollection 2017. Erratum In: Ann Gen Psychiatry. 2017 Mar 7;16:18.
Results Reference
result
PubMed Identifier
29731182
Citation
Kazemi A, Noorbala AA, Azam K, Eskandari MH, Djafarian K. Effect of probiotic and prebiotic vs placebo on psychological outcomes in patients with major depressive disorder: A randomized clinical trial. Clin Nutr. 2019 Apr;38(2):522-528. doi: 10.1016/j.clnu.2018.04.010. Epub 2018 Apr 24.
Results Reference
result
PubMed Identifier
26706022
Citation
Akkasheh G, Kashani-Poor Z, Tajabadi-Ebrahimi M, Jafari P, Akbari H, Taghizadeh M, Memarzadeh MR, Asemi Z, Esmaillzadeh A. Clinical and metabolic response to probiotic administration in patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial. Nutrition. 2016 Mar;32(3):315-20. doi: 10.1016/j.nut.2015.09.003. Epub 2015 Sep 28.
Results Reference
result

Learn more about this trial

Effect of Probiotic on Depression

We'll reach out to this number within 24 hrs