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| Name | Class |
|---|---|
| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
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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%. The high comorbidity rate between depression and constipation indicated the role of the gut-brain axis in depression. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively improve constipation and regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animals, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus plantarum) on the comorbidity of depression and constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Formula probiotic contains freeze-dried Lactobacillus paracasei, Bifidobacterium animals, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus plantarum, each at a dosage of 3.0 × 10^10 colony forming unit 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 receive 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. | Change from baseline score to intervention measurements at 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Constipation Symptom | Constipation symptoms as measured with the Patient Assessment of Constipation Symptom. The score ranges from 0 to 48. The higher score means severer constipated symptoms. | changes from baseline score to intervention measurements at 4 and 8 weeks |
| Serum Il-1β |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fazheng Ren, PhD | Contact | +86-10-62736344 | renfazheng@cau.edu.cn | |
| Xifan Wang, PHD | Contact | wangxfan@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Fazhen Ren, PhD | China Agricultural University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine | Nanjing | Jiangsu | 210001 | 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. | |
| 1531168 |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 receive the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ). |
|
Serum Il-1β levels before and after intervention assessed by ELISA. |
| changes from baseline level to intervention measurements at 4 and 8 weeks |
| Serum Il-6 | Serum Il-6 levels before and after intervention assessed by ELISA. | changes from baseline level to intervention measurements at 4 and 8 weeks |
| Serum TNF-α | Serum TNF-α levels before and after intervention assessed by ELISA. | changes from baseline level to intervention measurements at 4 and 8 weeks |
| Serum cortisol | Serum cortisol levels before and after intervention assessed by ELISA. | changes from baseline level to intervention measurements at 4 and 8 weeks |
| Serum Brain-derived neurotrophic factor | Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA. | changes from baseline level to intervention measurements at 4 and 8 weeks |
| Serum concentrations of tryptophan metabolites | Serum concentrations of tryptophan metabolites quantified by High-Performance Liquid Chromatography and Mass Spectrometry | Changes from baseline level to intervention measurements at 4 and 8 weeks |
| Serum concentrations of bile acid | Quantification by High-Performance Liquid Chromatography and Mass Spectrometry | Changes from baseline level to intervention measurements at 4 and 8 weeks |
| Fecal microbiome | Fecal microbiome measured by next generation sequencing | Changes from baseline to intervention measurements at 4 and 8 weeks |
| Stool form | Stool form measured with the Bristol Stool Form Scale, which classify the form of human faeces into seven types, successively named type 1 to type 7. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea. | Change from baseline score to intervention measurements at 4 and 8 weeks |
| Background |
| Walker EA, Katon WJ, Jemelka RP, Roy-Bryne PP. Comorbidity of gastrointestinal complaints, depression, and anxiety in the Epidemiologic Catchment Area (ECA) Study. Am J Med. 1992 Jan 24;92(1A):26S-30S. doi: 10.1016/0002-9343(92)90133-v. |
| 27814521 | Background | Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027. |
| 26218677 | Background | De Palma G, Blennerhassett P, Lu J, Deng Y, Park AJ, Green W, Denou E, Silva MA, Santacruz A, Sanz Y, Surette MG, Verdu EF, Collins SM, Bercik P. Microbiota and host determinants of behavioural phenotype in maternally separated mice. Nat Commun. 2015 Jul 28;6:7735. doi: 10.1038/ncomms8735. |
| 27288567 | 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 |