Clinical trial NCT03062332: The Gut Microbiota of Bipolar and Depression
Official title: Altered Fecal Microbiota Composition in Patients With Major Depressive Disorder and Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Major Depressive Disorder
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 240
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composition of the gut microbiota
timeFrame: 3 months
Secondary outcomes:
measure: metabolon
timeFrame: 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xiancang Ma
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Xiancang Ma, professor
role: STUDY_DIRECTOR
References: