Schizophrenia
Conditions
Interventions
Group A:Subjects will receive intraduodental administration of fecal bacteria by gastroscopy and oral placebo capsule.
Group B:Subjects will receive intraduodental administration of placebo by gastroscopy and oral fecal microbiota capsule.
Group C:Subjects will receive intraduodental administration of placebo by gastroscopy and oral placebo capsule.
Sponsors
The Affiliated Brain Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) aged 18-55 years; (2) meet the DSM - 5 diagnostic criteria for schizophrenia, and diagnosed as SZ for 15 years or less; (3) TRS (TRS) also must be in accordance with treatment-resistant schizophrenia patients, and the course of 10 years or less. Patients with TRS should meet following criteria: 1) the PANSS scale in any of the two symptoms are moderate, or a symptom is serious, the last 12 weeks or more; 2) moderate or more severe impairment, last 12 weeks or more. 3) sufficient foot procedures used by two or more different antipsychotics, each medicine for at least six weeks, a dose of 600 mg/d or chlorpromazine. (4) to understand the research content and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with contraindications to gastroscopy. Relative contraindications: 1) Cardiopulmonary insufficiency. 2) patients with gastrointestinal bleeding and unstable blood pressure; 3) patients with bleeding tendency and hemoglobin lower than 50g/L. 4) severe spinal deformity, giant esophageal or duodenal diverticulum. Absolute contraindications: 1) Severe heart and lung diseases, such as severe arrhythmia, acute myocardial infarction, severe heart failure, asthma attack, respiratory failure and so on. 2) patients with shock, gastrointestinal perforation and other critical patients. 3) Uncooperative patients with severe mental disorders (painless endoscopy can be performed if necessary). 4) patients with acute mouth or throat inflammation. 5) patients with acute corrosive inflammation of esophagus and stomach. 6) patients with obvious aortic aneurysm, acute cerebral infarction, and cerebral hemorrhage. 7) Patients with severe infectious diseases. (2) complicated with serious physical diseases, such as cardiovascular and cerebrovascular diseases, intracranial space-occupying diseases, intracranial hypertension, severe respiratory diseases, severe trauma, fractures, etc. (3) history of psychoactive substance abuse or dependence; (4) patients with severe intestinal barrier damage such as sepsis, active gastrointestinal bleeding and perforation caused by various reasons. (5) current diagnosis of fulminant colitis or toxic megacolon. (6) patients with severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high flow intestinal fistula and other diseases, who can not tolerate 50% of the calorie requirement of enteral nutrition. (7) patients with congenital or acquired immunodeficiency diseases. (8) recent treatment with high-risk immunosuppressive or cytotoxic drugs, such as rituximab, doxorubicin, or moderate-to-high dose steroids (prednisone 20 mg/ day or higher) for more than 4 weeks. (9) Severe immunosuppression: neutrophil count <1500/mm3 in adults and <1000/mm3 in children (10) pregnant or lactating women. (11) patients and their families disagree with FMT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS)score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (PANSS decreasing more than 20% compared to baseline);The Clinical Global Impressions (CGI) Scale;Personal and Social Performance Scale (PSP);The MATRICS Consensus Cognitive Battery (MCCB);Treatment Emergent Symptom (TESS) Scale; | — |
Countries
China
Contacts
Public ContactZezhi Li
The Affiliated Brain Hospital, Guangzhou Medical University
Outcome results
None listed