ITPNCT05118126
Gut Microbiota in ITP
An observational study of ITP, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITP
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100010
Xiao-Hui Zhang, doctor, zhangxh100@sina.com
Feng-Qi Liu, doctor, +8618301231630, liufengqi1230@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- ITP
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (4)
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
Measured: 3 months
AUC value of 6-month drug resistance/relapse using baseline gut microbiota
The prediction model is constructed and calculated using machine learning
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, Dr., Principal investigator, Peking University People's Hospital, Peking University Insititute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118126
- Sponsor's protocol ID
- PKU-ITP033
- Status last verified
- Jan 2022
- First submitted
- 1 Nov 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05118126
- Acronym / sponsor ID
- PKU-ITP033
- Conditions
- ITP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
Time frame: 3 months
AUC value of 6-month drug resistance/relapse using baseline gut microbiota
Time frame: 6 months
Time to response
Time frame: 6 months
Duration of response
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao-Hui Zhang, Dr. principal investigator
Peking University People's Hospital, Peking University Insititute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ITP, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Hui Zhang, Dr. (+8613522338836, zhangxh100@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.