Gut Microbiota in ITP

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia

Conditions
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ITP

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| AUC value of 6-month drug resistance/relapse using baseline gut microbiota | The prediction model is constructed and calculated using machine learning | 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. | 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 | 6 months |