Effect of Probiotic on Comorbidity of Depression and Constipation
NCT ID: NCT04570072
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-11-01
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic
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.
Probiotic
Patients receive the formula probiotic for consecutive 8 weeks ( one sachet per day ).
Placebo
Placebo made with only the excipients. The placebo sachet was matched to the study probiotic products for taste, color, and size.
Placebo
Patients receive the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
Interventions
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Probiotic
Patients receive the formula probiotic for consecutive 8 weeks ( one sachet per day ).
Placebo
Patients receive the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
Eligibility Criteria
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Inclusion Criteria
* Hamilton Rating Scale for Depression (HAMD-17) score not less than 8
* Meet the ROME III criteria for functional constipation
* Agreed to intake study product during the study period
* Agreed to sign written informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine
UNKNOWN
China Agricultural University
OTHER
Responsible Party
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Fazheng Ren
professor
Principal Investigators
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Fazhen Ren, PhD
Role: PRINCIPAL_INVESTIGATOR
China Agricultural University
Locations
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The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Min Ni, PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CAUDepression-02
Identifier Type: -
Identifier Source: org_study_id