Effect of Probiotic on Depression

NCT04567147 | Completed Phase 1

• 1 other identifier: CAUDepression-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Fecal microbiome

  Changes between at baseline and 8-week intervention

• Serum Il-1β

  change from baseline to intervention measurements at 8 weeks

• Serum Il-6

  change from baseline to intervention measurements at 8 weeks

• Serum TNF-α

  change from baseline to intervention measurements at 8 weeks

• Serum cortisol

  change from baseline to intervention measurements at 8 weeks

Study Arms (2)

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.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ).

Probiotic

Placebo DIETARY_SUPPLEMENT

Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Agricultural University: lead

Study Sites (1)

Beijing Chinese Medicine Hospital Pinggu Hospital

Beijing, China

Location

Related Publications (5)

• 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.

  PMID: 21791035 BACKGROUND

• 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.

  PMID: 27288567 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.

  PMID: 28239408 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.

  PMID: 29731182 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.

  PMID: 26706022 RESULT

MeSH Terms

Conditions

Depression

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 28, 2020
• Study Start: November 20, 2018
• Primary Completion: June 22, 2019
• Study Completion: September 12, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)