Gut Microbiota in ITP

• Conditions: ITP

• Registration Number: NCT05118126
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Status Verified: 2022-01
• Study Start: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-12
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model	1 month	The prediction model is constructed and calculated using machine learning methods

Secondary Outcome Measures

Name	Time	Method
AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model	3 months	The prediction model is constructed and calculated using machine learning
AUC value of 6-month drug resistance/relapse using baseline gut microbiota	6 months	The prediction model is constructed and calculated using machine learning
Duration of response	6 months	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 to response	6 months	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.

Trial Locations

Locations (1)

Peking University Insititute of Hematology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China