The Gut Microbiota of Bipolar and Depression

Altered Fecal Microbiota Composition in Patients With Major Depressive Disorder and Bipolar Disorder

Background: The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. Investigators aim at elucidating the complement of the gut microbiome community for individuals with Major Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for relationships with symptoms.

Methods: Investigators prospect to recruit subjects including patients and controls amount to 240. All subjects will be collected for blood and stool samples,assessed by clinical scales. Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and clinical scales to obtain the possible interaction between diseases and gut microbiota.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Genetic: Faecal genome

Detailed Description

Background: MDD (Major Depressive disorder) and BD (Bipolar disorder), whose specific pathogenesis is still unclear, are both a multi-factorial disease being caused by biological, psychological and social factors. Accumulating evidence suggests that gut microbiota play an important role in brain functions and in the pathogenesis of neuropsychiatric diseases, such as autism, anxiety, as well as depression. No study has thus far compared the human gut microbiota among BD, MDD and the healthy control (HC). The aim of this study is to compare the composition of fecal microbiota among BD, MDD and HC. Furthermore, investigators aim at identifying direct correlations between human fecal microbiota (as a proxy for gut microbiota) and symptoms.

Methods:

1. Investigators aim at recruiting human subjects in total 240, which including mania episode of bipolar disorder (40), depressive episode of bipolar disorder (40), mixed episode of bipolar disorder (40), first episode of major depressive disorder (40), recurrent episode of major depressive disorder (40), and healthy control (40). All patients, diagnosed according to the research criteria of the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10）, come from The First Affiliated Hospital of Xi'an Jiaotong University and controls are healthy volunteers.
2. Collecting blood and stool samples, evaluating clinical scales including Montgomery-Asberg Depression Scale (MADRS), Young Mania Rating Scale (YMRS), Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Measurement And Treatment Research To Improve Cognition In Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB), Clinical Global Impression (CGI) are all finished in first day after threshold.
3. Measure the metabolon in blood such as S-CFA, and gut microbiota.
4. Using Statistical Program for Social Sciences (SPSS) to compare general and clinical data among groups and analyze the correlation between the microbiota and symptoms.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Xiancang Ma, professor; Phone Number: 13002951782; Email: maxiancang@163.com
• Study Contact Backup: Name: Wei Wang; Phone Number: 86-13991985805; Email: xianwv@sina.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • Xiancang Ma
      • Contact: Xiancang Ma, professor; Phone Number: +8613002951782; Email: maxiancang@163.com
      • Contact: Wei Wang, doctor; Phone Number: 86-13991985805; Email: xianwv@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are someone who are hospitalized in First Affiliated Hospital of Xi'an Jiaotong University.

Healthy controls are healthy volunteers.

Description

Inclusion Criteria:

• Conforms to the diagnosis of bipolar disorder or major depressive disorder.
• Take antibiotics continuously less than 3 days in recent 3 months.
• 17.5≦BMI≦30
• Age≦65

Exclusion Criteria:

• who is diagnosed with physical diseases and other mental diseases.
• pregnant or lactational women
• who is diagnosed with mental retardation.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bipolar disorder,mania; The group includes subjects who are diagnosed to mania episode of bipolar disorder.	Genetic: Faecal genome; Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
Bipolar disorder,depressive; The group includes subjects who are diagnosed to depression episode of bipolar disorder.	Genetic: Faecal genome; Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
Bipolar disorder,mixed; The group includes subjects who are diagnosed to mixed episode of bipolar disorder.	Genetic: Faecal genome; Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
First episode major depression; The group includes subjects who are diagnosed to first episode of major depression.	Genetic: Faecal genome; Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
major depression，recurrent; The group includes subjects who are diagnosed to recurrent episode of major depression.	Genetic: Faecal genome; Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
Healthy control; The group includes subjects who are Healthy control.	Genetic: Faecal genome; Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of the gut microbiota	The relative richness of the species, %	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
metabolon	the concentration of short-chain fatty acid(S-CFA), μg/ml	3 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Director: Xiancang Ma, professor, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2020
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Disease; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: TGMOBAD2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No