Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ITP
- Sponsor
- Peking University People's Hospital
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
- Last Updated
- 4 years ago
Overview
Brief Summary
Prospective, observational study to explore the significance of gut microbiome in the diagnosis of ITP, and to identify the predictive value of baseline gut microbiome for GC resistance/relapse.
Detailed Description
A prospective, observational study to (1) collect fecal samples from ITP patients at initial diagnosis (baseline) and after first-line GC treatment, (2) detect the composition of gut microbiome and related metabolites using metagenomic sequencing combined with metabolomics, (3) observe the impact of first-line treatment on gut microbiome, (4) explore the significance of gut microbiome in the diagnosis of ITP, and (5) identify the predictive value of baseline gut microbiome for GC resistance/relapse, thus to provide new ideas for clinical diagnosis and treatment of ITP.
Investigators
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •18 years or older;
- •Isolated thrombocytopenia (platelet count of less than 100×10\^9/L);
- •Normal leukocyte and erythrocyte counts according to routine blood tests;
- •Did not receive any medication for thrombocytopenia for 6 months.
Exclusion Criteria
- •Secondary ITP such as drug-associated thrombocytopenia;
- •Thrombocytopenia caused by viral infection (HIV, Hepatitis B virus or Hepatitis C virus);
- •Nursing or pregnant women;
- •Severe dysfunction of the heart, kidney, lung or liver;
- •Active or previous malignancy;
- •Patients with other diseases were undergoing treatment with immunosuppressants;
- •Myelodysplastic disorder or myelofibrosis;
- •Patients who were undergoing first - or second-line therapy for thrombocytopenia within 6 months.
Outcomes
Primary Outcomes
AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
Time Frame: 1 month
The prediction model is constructed and calculated using machine learning methods
Secondary Outcomes
- AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model(3 months)
- AUC value of 6-month drug resistance/relapse using baseline gut microbiota(6 months)
- Duration of response(6 months)
- Time to response(6 months)