Gut Microbiota in ITP

NCT05118126 | Unknown DMC

• 1 other identifier: PKU-ITP033
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

ITP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model

  3 months

• AUC value of 6-month drug resistance/relapse using baseline gut microbiota

  6 months

• Time to response

  6 months

• Duration of response

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Hospital: collaborator

Study Sites (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal sample collection and metagenomic sequencing: A specific stool sample collector was selected to collect an appropriate amount of stool samples (≥1g/ sample). Samples that could not be extracted immediately were transported on dry ice and stored at -80℃. DNA was extracted by phenol/chloroform method. Qubit Fluorometer is used to test samples DNA concentration, agarose gel electrophoresis (gel concentration: 1%; Voltage: 150 V; Electrophoresis time: 40 min) is used to test DNA integrity of samples, and unqualified samples with insufficient DNA amount or degradation were eliminated. Qualified samples were used for DNA library construction and Illumina sequencing. The sequencing library was constructed according to Illumina's official operating instructions and further optimized. Qualified libraries were sequenced using Illumina platform.

Study Officials

• Xiao-Hui Zhang, Dr.

  Peking University People's Hospital, Peking University Insititute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, Dr.

CONTACT

+8613522338836; zhangxh100@sina.com

Feng-Qi Liu, MD.

CONTACT

+8618301231630; liufengqi1230@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

CN (1)