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Study on the Mechanism of Oropharyngeal CRE Colonization and Decolonization in Hematopoietic Stem Cell Transplantation Patients Based on Microbiome and Metabonomics

To Confirm the Clinical Significance of Screening Oropharyngeal Opportunistic Colonization Microorganisms in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Based on High-Throughput Sequencing and Traditional Culture

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069450
Enrollment
Unknown
Registered
2023-03-16
Start date
2022-05-27
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

Case series:No

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects suitable for inclusion in this study must meet all of the following criteria: 1. Recipients of allogeneic hematopoietic stem cell transplantation (including HLA matched or incomplete matched allogeneic hematopoietic stem cell transplantation and unrelated donor transplantation); 2. Aged >= 15 years and < 70 years, male or female; 3. The ECOG-ps score of Eastern oncology cooperation group is 0-2; 4. The informed consent form must be signed before the start of the research procedure. For those aged 18 or above, the informed consent form shall be signed by the patient himself or his immediate family members; The legal guardian shall sign the informed consent form for children and adolescents under 18 years old. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member shall sign the informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria shall not be selected for this study: 1. Pulmonary and digestive tract active infection was identified before transplantation; 2. The serological reaction of HIV or active hepatitis C virus is known to be positive; 3. Suffering from mental illness or other diseases and unable to cooperate with the requirements of research treatment and monitoring; 4. Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 5. Received hematopoietic stem cell transplantation in the past year; 6. Active heart disease is defined as one or more of the following: (1) History of uncontrolled or symptomatic angina pectoris; (2) Myocardial infarction less than 6 months before the study; (3) A history of arrhythmia requiring medication or with severe clinical symptoms; (4) Uncontrolled or symptomatic congestive heart failure (> NYHA grade 2); (5) The ejection fraction was lower than the lower limit of the normal range; (6) Patients who refused to be enrolled in the study.

Design outcomes

Primary

MeasureTime frame
oropharyngeal swab sequencing;Blood culture sequencing;oropharyngeal swab culture;Blood culture;

Secondary

MeasureTime frame
Overall survival;aGVHD;EBV infection;CMV infection;Oral and oropharyngeal mucositis;

Countries

China

Contacts

Public ContactJisheng Liu; Depei Wu

The First Affiliated Hospital of Soochow University

ljswwq@sina.com+86 13506216162; +86 13951102021

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026