Effect of Probiotic on Comorbidity of Depression and Constipation

NCT04570072 | Unknown

• 1 other identifier: CAUDepression-02
• Study Type: interventional
• Target: 200
• 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%. 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.

Conditions

Comorbidity of Depression and Constipation

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.

  Change from baseline score to intervention measurements at 4 and 8 weeks

Secondary Outcomes (10)

• Patient Assessment of Constipation Symptom

  changes from baseline score to intervention measurements at 4 and 8 weeks

• Serum Il-1β

  changes from baseline level to intervention measurements at 4 and 8 weeks

• Serum Il-6

  changes from baseline level to intervention measurements at 4 and 8 weeks

• Serum TNF-α

  changes from baseline level to intervention measurements at 4 and 8 weeks

• Serum cortisol

  changes from baseline level to intervention measurements at 4 and 8 weeks

Study Arms (2)

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.

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

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal body mass index ≥ 18.5 until ≤ 29.9
• 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

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
• The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine: collaborator

Study Sites (1)

The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210001, China

Location

Related Publications (8)

• 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

• 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.

  PMID: 1531168 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.

  PMID: 27814521 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.

  PMID: 26218677 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

Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fazhen Ren, PhD

  China Agricultural University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fazheng Ren, PhD

CONTACT

+86-10-62736344; renfazheng@cau.edu.cn

Xifan Wang, PHD

CONTACT

wangxfan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 30, 2020
• Study Start: November 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)