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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 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 | Placebo Comparator | Placebo made with only the excipients. The placebo sachet was matched to the study probiotic products for taste, color, and size. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiome | changes in the profile of gut microbiota before and after 8-week intervention. | Changes between at baseline and 8-week intervention |
| Serum Il-1β | Serum Il-1β levels before and after intervention assessed by ELISA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chinese Medicine Hospital Pinggu Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21791035 | Background | 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. | |
| 27288567 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ). |
|
| change from baseline to intervention measurements at 8 weeks |
| Serum Il-6 | Serum Il-6 levels before and after intervention assessed by ELISA. | change from baseline to intervention measurements at 8 weeks |
| Serum TNF-α | Serum TNF-α levels before and after intervention assessed by ELISA. | change from baseline to intervention measurements at 8 weeks |
| Serum cortisol | Serum cortisol levels before and after intervention assessed by ELISA. | change from baseline to intervention measurements at 8 weeks |
| 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 |
| Result |
| 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. |
| 28239408 | Result | 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. |
| 29731182 | Result | 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. |
| 26706022 | Result | 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. |
| D019602 |
| Food and Beverages |