SchizophreniaNCT02708316
The Gut Metagenome Research of Schizophrenia
An observational study of Schizophrenia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- sequencing faecal metagenome
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Xiancang Ma, MD,PHD, 008613002951782, maxiancang@163.com
About this study
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.
Read the 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:
- 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;
- 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.
- 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.
- Conditions
- Schizophrenia
- Being tested
- sequencing faecal metagenome
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequencing faecal metagenomeGenetic
sequencing faecal metagenome is not the intervention measure.It is the observational method for investigators to detect the component of faecal microorganism.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia group | schizophrenia patients in the group Receives: Genetic: sequencing faecal metagenome | |
| control group | healthy population Receives: Genetic: sequencing faecal metagenome |
What is being measured
The primary outcome is the main question the study is designed to answer.
species-level molecular operational taxonomic units
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.
Measured: at the beginning
species-level molecular operational taxonomic units
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.
Measured: the third month
Secondary outcomes (15)
concentration of inflammatory factors
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
Measured: at the beginning
concentration of inflammatory factors
concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL
Measured: the third week
concentration of inflammatory factors
concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL
Measured: the third month
concentration of inflammatory factors
concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL
Measured: the sixth month
concentration of inflammatory factors
concentration of inflammatory factors including IL-1,IL-10,IL-2,IL-6,TNF, the measure unit is U/mL
Measured: one year
concentration of γ-aminobutyric acid
γ-aminobutyric acid was measured by high efficiency liquid chromatography in cerebrospinal fluid, the measure unit is mg/kg
Measured: at the beginning
concentration of γ-aminobutyric acid
γ-aminobutyric acid was measured by high efficiency liquid chromatography in cerebrospinal fluid, the measure unit is mg/kg
Measured: the sixth month
gene profiles
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.
Measured: at the beginning
gene profiles
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.
Measured: the third month
metagenomic linkage groups
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.
Measured: at the beginning
metagenomic linkage groups
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.
Measured: the third month
Encyclopedia of Genes and Genomes (KEGG) ortholog
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.
Measured: at the beginning
Encyclopedia of Genes and Genomes (KEGG) ortholog
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.
Measured: the third month
module and pathway profiles of faecal microbiota
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.
Measured: at the beginning
module and pathway profiles of faecal microbiota
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.
Measured: the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of Bao Ji City, Center Hospital of Xian Yang City, Mental Health Center of Wei Nan City
- Responsible party
- Sponsor
- Investigators
- Xiancang Ma, MD,PHD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708316
- Sponsor's protocol ID
- XJTU1AF-CRS-2015-009
- Status last verified
- Aug 2021
- First submitted
- 3 Mar 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Metagenome Research of Schizophrenia
- ClinicalTrials.gov ID
- NCT02708316
- Acronym / sponsor ID
- XJTU1AF-CRS-2015-009
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of Bao Ji City, Center Hospital of Xian Yang City, Mental Health Center of Wei Nan City
- Study start
- Apr 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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;
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia group | – | Genetic: sequencing faecal metagenomeschizophrenia patients in the group |
| control group | – | Genetic: sequencing faecal metagenomehealthy population |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sequencing faecal metagenomesequencing faecal metagenome is not the intervention measure.It is the observational method for investigators to detect the component of faecal microorganism. | Genetic | control group, schizophrenia group |
Primary outcome
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.
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.
15 secondary outcomes
concentration of inflammatory factors
Time frame: at the beginning
concentration of inflammatory factors
Time frame: the third week
concentration of inflammatory factors
Time frame: the third month
concentration of inflammatory factors
Time frame: the sixth month
concentration of inflammatory factors
Time frame: one year
concentration of γ-aminobutyric acid
Time frame: at the beginning
concentration of γ-aminobutyric acid
Time frame: the sixth month
gene profiles
Time frame: at the beginning
gene profiles
Time frame: the third month
metagenomic linkage groups
Time frame: at the beginning
metagenomic linkage groups
Time frame: the third month
Encyclopedia of Genes and Genomes (KEGG) ortholog
Time frame: at the beginning
Encyclopedia of Genes and Genomes (KEGG) ortholog
Time frame: the third month
module and pathway profiles of faecal microbiota
Time frame: at the beginning
module and pathway profiles of faecal microbiota
Time frame: the third month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiancang Ma, MD,PHD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiancang Ma, MD,PHD (008613002951782, maxiancang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
species-level molecular operational taxonomic units (time frame: at the beginning). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.