Gut Microbiota in ITP

ITP Clinical Trial

Official title:

Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118126
• Other study ID #: PKU-ITP033
• Status: Recruiting
• Start date: January 2022
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Peking University People's Hospital
• Contact: Xiao-Hui Zhang, Dr.
• Phone: +8613522338836
• Email: zhangxh100[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ITP

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	AUC value of 6-month drug resistance/relapse using baseline gut microbiota	The prediction model is constructed and calculated using machine learning	6 months
Secondary	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
Secondary	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