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The Gut Metagenome Research of Schizophrenia

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ClinicalTrials.gov Identifier: NCT02708316
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
Rehabilitation Hospital of Bao Ji City
Center Hospital of Xian Yang City
Mental Health Center of Wei Nan City
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
Research already found that patients with autistic spectrum disorders lack of Prevotella intestinal type, then schizophrenia patients may also show the specific intestinal type, so investigators want to detect the gut metagenome of schizophrenia patients by high-throughput DNA sequencing to find specific intestinal type, so as to achieve the purpose of schizophrenia diagnosis. According to the detection of inflammatory factors in the blood, nerve growth factor in the cerebrospinal fluid, to find the mechanism of the gut-microbes-brain axis. Furthermore, investigators want to identify intestinal strains involved in weight gain and metabolic disorders such as blood glucose and lipids induced by antipsychotic drugs.

Condition or disease Intervention/treatment
Schizophrenia Genetic: sequencing faecal metagenome

Detailed Description:

A prospective observational study will be conducted and cases will be recruited by multi-center cooperation. Investigators plan to collect 100 schizophrenic patients as case group, 100 healthy people as control group. Investigators will observe schizophrenia patients who use the single drug of risperidone in the treatment and follow up the patients on day 1, the third week, the third month, the sixth month and the first year. In addition, the other two groups of patients with schizophrenia will be included, one with olanzapine and the other with aripiprazole. There are three objectives:

  1. Compare healthy population with schizophrenia patients in the difference of gut metagenome and inflammatory factors in the blood, stool samples aimed at detecting the difference of composition of intestinal microorganism;
  2. Observe the change of intestinal microorganism, inflammatory factors, γ-aminobutyric acid of schizophrenic patients who received risperidone treatment according to the blood, stool samples, cerebrospinal fluid during the follow-up period.
  3. Study the difference of intestinal flora composition between schizophrenia patients with metabolic disorder and schizophrenia patients without metabolic disorder after olanzapine or aripiprazole treatment and discuss the relationship between intestinal flora composition and metabolic disorder.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Gut Metagenome Research of Schizophrenia
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
schizophrenia group
schizophrenia patients in the group
Genetic: sequencing faecal metagenome
sequencing faecal metagenome is not the intervention measure.It is the observational method for investigators to detect the component of faecal microorganism.

control group
healthy population
Genetic: sequencing faecal metagenome
sequencing faecal metagenome is not the intervention measure.It is the observational method for investigators to detect the component of faecal microorganism.




Primary Outcome Measures :
  1. species-level molecular operational taxonomic units [ Time Frame: at the beginning ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain species-level molecular operational taxonomic units.

  2. species-level molecular operational taxonomic units [ Time Frame: the third month ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain species-level molecular operational taxonomic units.


Secondary Outcome Measures :
  1. concentration of inflammatory factors [ Time Frame: at the beginning ]
    concentration of inflammatory factors including interleukin-1(IL-1),interleukin-10(IL-10),interleukin-2 (IL-2),interleukin-6 (IL-6),tumor necrosis factor (TNF), the measure unit is U/mL

  2. concentration of inflammatory factors [ Time Frame: the third week ]
    concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL

  3. concentration of inflammatory factors [ Time Frame: the third month ]
    concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL

  4. concentration of inflammatory factors [ Time Frame: the sixth month ]
    concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL

  5. concentration of inflammatory factors [ Time Frame: one year ]
    concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL

  6. concentration of γ-aminobutyric acid [ Time Frame: at the beginning ]
    γ-aminobutyric acid was measured by high efficiency liquid chromatography in cerebrospinal fluid, the measure unit is mg/kg

  7. concentration of γ-aminobutyric acid [ Time Frame: the sixth month ]
    γ-aminobutyric acid was measured by high efficiency liquid chromatography in cerebrospinal fluid, the measure unit is mg/kg

  8. gene profiles [ Time Frame: at the beginning ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain gene profiles.

  9. gene profiles [ Time Frame: the third month ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain gene profiles.

  10. metagenomic linkage groups [ Time Frame: at the beginning ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain metagenomic linkage groups.

  11. metagenomic linkage groups [ Time Frame: the third month ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain metagenomic linkage groups.

  12. Encyclopedia of Genes and Genomes (KEGG) ortholog [ Time Frame: at the beginning ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain Encyclopedia of Genes and Genomes (KEGG) ortholog.

  13. Encyclopedia of Genes and Genomes (KEGG) ortholog [ Time Frame: the third month ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain Encyclopedia of Genes and Genomes (KEGG) ortholog.

  14. module and pathway profiles of faecal microbiota [ Time Frame: at the beginning ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain module and pathway profiles of faecal microbiota.

  15. module and pathway profiles of faecal microbiota [ Time Frame: the third month ]
    The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain module and pathway profiles of faecal microbiota.


Biospecimen Retention:   Samples With DNA
stool samples retained for sequencing faecal metagenome


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The cases included the first episode or recurrent acute-exacerbation schizophrenia patients who correspond to the DSM-Ⅵ diagnostic criteria. The healthy population is matched with cases based on gender, age, nationality, smoking, diet, education and socioeconomic status.
Criteria

Inclusion Criteria:

  • The first episode or recurrent acute-exacerbation schizophrenia patients who correspond to the Diagnostic and Statistical Manual of Mental Disorders-Ⅵ (DSM-Ⅵ) diagnostic criteria.
  • Between 18 and 45 years old (including 18 and 45 years old, male or female).
  • Patients never accepted full range of psychotropic drugs before admission(taking psychotropic drug less than 5 days before admission)
  • the duration of recurrent patients is less than 5 years
  • the period of taking psychiatric drug before admission is no more than 2 weeks.
  • didn't use of antibiotics within consecutive 3 days in recent 3 months.
  • meet the indications of a single antipsychotic risperidone treatment.
  • All the patients must have a good family support and comply with the requirements and signed informed consent
  • The PANSS score is greater than 60 or equal to 60.
  • BMI is greater than or equal 17.5 and less than or equal to 30.

Exclusion Criteria:

  • Patients have severe unstable cardiovascular disease, liver disease, kidney disease, blood disease and endocrine disease or history.
  • Patients have the history of systematic disease or history of malignant tumor or relevant complications.
  • Patients have the activity of gastrointestinal diseases.
  • Patients have organic brain disease or complications and mental retardation.
  • According to the DSM-Ⅵ diagnostic criteria , patients have drug abuse or drug dependence and incomplete remission.
  • glutamic-oxalacetic transaminase (AST) or glutamic-pyruvic transaminase (ALT) is 2 times higher than the normal limit.
  • Renal dysfunction, creatinine is higher than the upper limit of normal value.
  • The women in pregnancy or lactation now, and may be in pregnant during the study period.
  • Patients are allergic to risperidone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708316


Contacts
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Contact: Xiancang Ma, MD,PHD 008613002951782 maxiancang@163.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xian Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Xiancang Ma, MD,PHD    008613002951782    maxiancang@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Rehabilitation Hospital of Bao Ji City
Center Hospital of Xian Yang City
Mental Health Center of Wei Nan City
Investigators
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Principal Investigator: Xiancang Ma, MD,PHD First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02708316     History of Changes
Other Study ID Numbers: XJTU1AF-CRS-2015-009
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders