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Gut Microbiota in ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05118126
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : January 12, 2022
Sponsor:
Collaborator:
Beijing Hospital
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Study Description
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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
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 Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    The prediction model is constructed and calculated using machine learning

  3. Time to response [ Time Frame: 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 [ Time Frame: 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


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05118126


Contacts
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Contact: Xiao-Hui Zhang, Dr. +8613522338836 zhangxh100@sina.com
Contact: Feng-Qi Liu, MD. +8618301231630 liufengqi1230@163.com

Locations
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China, Beijing
Peking University Insititute of Hematology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100010
Contact: Xiao-Hui Zhang, doctor       zhangxh100@sina.com   
Contact: Feng-Qi Liu, doctor    +8618301231630    liufengqi1230@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Beijing Hospital
Investigators
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Principal Investigator: Xiao-Hui Zhang, Dr. Peking University People's Hospital, Peking University Insititute of Hematology
More Information
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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: November 11, 2021    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No