Gut Microbiota in ITP

Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia

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.

Study Overview

• Status: Recruiting
• Conditions: ITP

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 Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Xiao-Hui Zhang, Dr.; Phone Number: +8613522338836; Email: zhangxh100@sina.com
• Study Contact Backup: Name: Feng-Qi Liu, MD.; Phone Number: +8618301231630; Email: liufengqi1230@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Peking University Insititute of Hematology, Peking University People's Hospital
      • Contact: Xiao-Hui Zhang, doctor; Email: zhangxh100@sina.com
      • Contact: Feng-Qi Liu, doctor; Phone Number: +8618301231630; Email: liufengqi1230@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed ITP who would receive first-line therapy (glucocorticoid therapy with platelet infusion) according to the clinician's or patient's decision.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Beijing Hospital
• Investigators: Principal Investigator: Xiao-Hui Zhang, Dr., Peking University People's Hospital, Peking University Insititute of Hematology

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PKU-ITP033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No