Gut Microbiota in ITP | NCT05118126

Studies
Gut Microbiota in ITP

NCT05118126

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Jan 12, 2022Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Jun 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Nov 1, 2021

First Submission Date that Met QC Criteria

Nov 1, 2021

First Posted Date

Nov 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2022

Last Update Posted Date

Jan 12, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Name	Class
Beijing Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiao-Hui Zhang, Dr.	Contact	+8613522338836		zhangxh100@sina.com
Feng-Qi Liu, MD.	Contact	+8618301231630		liufengqi1230@163.com

Overall Officials

Name	Affiliation	Role
Xiao-Hui Zhang, Dr.	Peking University People's Hospital, Peking University Insititute of Hematology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Insititute of Hematology, Peking University People's Hospital	Recruiting	Beijing	Beijing Municipality	100010	China

Description

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.