Gut Microbiota in ITP

Peking University

Status: Unknown

Conditions: ITP

Study type: Observational

Funder types: Other

Identifiers

NCT05118126

PKU-ITP033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.