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Gut Microbiota in ITP

Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05118126
Collaborator
Beijing Hospital (Other)
240
Enrollment
1
Location
11
Anticipated Duration (Months)
21.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia
    Anticipated Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. AUC value of 6-month drug resistance/relapse using baseline gut microbiota [6 months]

      The prediction model is constructed and calculated using machine learning

    3. 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.

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Insititute of Hematology, Peking University People's Hospital Beijing Beijing China 100010

    Sponsors and Collaborators

    • Peking University People's Hospital
    • Beijing Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05118126
    Other Study ID Numbers:
    • PKU-ITP033
    First Posted:
    Nov 11, 2021
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 12, 2022