Severe Fever with Thrombocytopenia Syndrome
Conditions
Interventions
Experimental group:Oral transplantation of lyophilized powder preparations of gut microbiota+Standard treatment group
Standard treatment group:Standard treatment group+placebo
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Severe Fever with Thrombocytopenia Syndrome (SFTS) according to the Expert Consensus on the Diagnosis and Treatment of Severe Fever with Thrombocytopenia Syndrome (2023 Edition) and the Diagnosis and Treatment Protocol for Severe Fever with Thrombocytopenia Syndrome (2023 Edition) issued by the National Health Commission of China, as defined by meeting at least one of the following criteria: (1) Positive SFTSV nucleic acid test (viral load > 10 TCID50/mL); (2) SFTSV isolated and cultured from a clinical specimen; (3) Seroconversion of SFTSV-IgG or a >= 4-fold increase in antibody titer in the convalescent phase compared to the acute phase. 2. Patients initially diagnosed with SFTS; aged 18–75 years; with stable vital signs; time from symptom onset to hospital admission <= 7 days. 3. Patients must be able to communicate well with the investigator, voluntarily agree to participate in the trial after understanding the study content and potential risks, and sign the informed consent form approved by the ethics committee before beginning any trial-specified procedures. 4. Willing to take the relevant oral formulation.
Exclusion criteria
Exclusion criteria: 1. Confirmed co-infection with various types of pathogens including bacteria, fungi, viruses, and atypical pathogens; viral infections other than viral hepatitis and Epstein-Barr virus. 2. Presence of unstable vital signs upon admission (heart rate>120 bpm, blood pressure30 breaths/min), significant bleeding tendency (platelet count180 mmHg or diastolic blood pressure>110 mmHg; acute phase of cerebral infarction; acute phase of cerebral hemorrhage; history of heart valve replacement, etc.); Liver diseases (Child-Pugh Class C); Kidney diseases (Chronic Kidney Disease (CKD) Stage IV-V); Endocrine and metabolic disorders (diabetic ketoacidosis or hyperosmolar state; history of poorly controlled blood glucose; HbA1c > 9.0%, daily blood glucose fluctuation>5.5 mmol/L); Trauma (acute injury phase; within 2 weeks before or after surgery). Patients with well-controlled symptoms may be considered for enrollment after evaluation by the expert panel (e.g., patients with claudication due to cerebral infarction). 5. Inability to take the oral formulation due to conditions such as peptic ulcer disease or reflux esophagitis. 6. Diagnosis of any malignancy (e.g., hematologic malignancies, gastric cancer, colon cancer, cholangiocarcinoma, esophageal cancer, liver cancer, lung cancer, gastric cancer, etc.); presence of uncontrolled autoimmune disease with gastrointestinal involvement (e.g., untreated systemic lupus erythematosus). 7. Patient and/or family members unwilling to participate or unable to complete the follow-up procedures. 8. Immunocompromised or allergic status: known allergy to any component of the formulation; history of severe immune reactions; long-term use of high-dose immunosuppressants; patients with congenital or acquired immunodeficiencies. 9. Children, pregnant or breastfeeding women; patients with a prior diagnosis of psychiatric disorders; patients aged > 75 years. 10. Severe immunosuppression (white blood cell count<1.0×10?/L or absolute neutrophil count<0.5×10?/L). If this condition is solely attributable to SFTS, careful consideration may be given to enrollment after unanimous discussion by the expert panel; 11. Contraindications related to intestinal diseases: patients with severe impairment of the intestinal barrier due to various causes, such as sepsis, active massive gastrointestinal bleeding, or perforation; current diagnosis of fulminant colitis or toxic megacolon; inability to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic strictures, severe gastrointestinal bleeding, ulcerative colitis, Crohn's disease, high-output intestinal fistula, etc. 12. Severe malnutrition (BMI<15) with fecal incontinence; 13. Other conditions deemed unsuitable for enrollment by the investigators, such as: history of hematopoietic stem cell transplantation or organ transplantation; inability to tolerate colonoscopy; recent relevant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dynamic changes of immune cells in PBMC;Case Fatality Rate;Severe case rate;SFTSV RNA level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Advised events; | — |
Countries
China
Contacts
Public ContactYufeng Gao
The first affiliated hospital of anhui medical university
Outcome results
None listed