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.
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.
Study Type
OBSERVATIONAL
Enrollment
240
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGAUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
The prediction model is constructed and calculated using machine learning methods
Time frame: 1 month
AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
The prediction model is constructed and calculated using machine learning
Time frame: 3 months
AUC value of 6-month drug resistance/relapse using baseline gut microbiota
The prediction model is constructed and calculated using machine learning
Time frame: 6 months
Time to response
The time to achieve platelet count ≥ 30×10\^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.
Time frame: 6 months
Duration of response
The duration of achieve platelet count ≥ 30×10\^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment
Time frame: 6 months
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