An observational study in ITP, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by Peking University People's Hospital · Observational
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.
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.
Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Time frame: 1 month
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
Time frame: 3 months
AUC value of 6-month drug resistance/relapse using baseline gut microbiota
The prediction model is constructed and calculated using machine learning
Time frame: 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.
Time frame: 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
Time frame: 6 months
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital