Effect of Probiotic on Depression

Depression Clinical Trial

Official title:

Effect of Probiotic on Depressive Symptom in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567147
• Other study ID #: CAUDepression-01
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2018
• Est. completion date: September 12, 2020

Study information

• Verified date: September 2020
• Source: China Agricultural University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 12, 2020
• Est. primary completion date: June 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• Probiotic
Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ).
• Placebo
Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).

Locations

Country	Name	City	State
China	Beijing Chinese Medicine Hospital Pinggu Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Agricultural University

Country where clinical trial is conducted

China, 

References & Publications (5)

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; — View 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, — View 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, Lépine 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. — View 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.cln — View 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. Review. Erratum in: Ann Gen Psychiatry. 2017 Mar 7;16:18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Changes in the HAMD score at baseline and 8-week intervention
Secondary	Fecal microbiome	changes in the profile of gut microbiota before and after 8-week intervention.	Changes between at baseline and 8-week intervention
Secondary	Serum Il-1ß	Serum Il-1ß levels before and after intervention assessed by ELISA.	change from baseline to intervention measurements at 8 weeks
Secondary	Serum Il-6	Serum Il-6 levels before and after intervention assessed by ELISA.	change from baseline to intervention measurements at 8 weeks
Secondary	Serum TNF-a	Serum TNF-a levels before and after intervention assessed by ELISA.	change from baseline to intervention measurements at 8 weeks
Secondary	Serum cortisol	Serum cortisol levels before and after intervention assessed by ELISA.	change from baseline to intervention measurements at 8 weeks
Secondary	Serum Brain-derived neurotrophic factor	Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA.	change from baseline to intervention measurements at 8 weeks