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임상시험 NCT06788769은(는) 클로스트리디오이데스 디피실레 감염에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Study of Clostridioides Difficile in Infants 300 바이오마커 기반 예방적
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06788769은(는) 클로스트리디오이데스 디피실레 감염에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2024년 7월 1일에 시작되어 300명의 참여자를 모집하고 있습니다. Westlake University이(가) 진행하며, 2026년 12월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 1월 23일에 갱신되었습니다.
간단한 개요
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy...더 보기
공식 제목
Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection
질환명
클로스트리디오이데스 디피실레 감염기타 연구 식별자
- 20241202TL001
NCT 번호
실제 연구 시작일
2024-07-01
최신 업데이트 게시
2025-01-23
예상 연구 완료일
2026-12-30
계획된 등록 인원
300
연구종류
관찰연구
상태
모집중
키워드
Clostridioides Difficile
Infants
Infants
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
CDI Patients This group includes infants aged 0-2 years who have been diagnosed with Clostridioides difficile infection (CDI). Diagnosis is based on clinical symptoms such as diarrhea, abdominal pain, or fever, along with positive laboratory confirmation (e.g., stool PCR or culture for C. difficile). | 해당 없음 |
Asymptomatic Clostridioides difficile Carriers This group includes infants aged 0-2 years who are colonized with Clostridioides difficile but show no clinical symptoms of infection. Participants in this group tested positive for C. difficile in fecal samples collected during routine or study-related screening. | 해당 없음 |
Healthy Infants This group includes infants aged 0-2 years who do not show any clinical symptoms of infection and have tested negative for Clostridioides difficile in fecal samples. Participants were recruited from general pediatric clinics or community health programs. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants | The prevalence of CDI and asymptomatic C. difficile carriage will be determined by testing fecal samples for C. difficile using PCR and/or culture methods. Participants are categorized into three groups based on clinical symptoms (diarrhea, abdominal pain, or fever) and laboratory confirmation (positive PCR or stool culture).
Specifically, the primary outcome assesses:
1. The proportion of infants (0-2 years) testing positive for C. difficile who exhibit clinical symptoms (CDI patients).
2. The proportion of infants (0-2 years) testing positive but showing no symptoms (asymptomatic carriers), and the proportion of infants testing negative (healthy controls). | Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Gut Microbial Diversity Among CDI Patients, Asymptomatic Carriers, and Healthy Controls | Metagenomic sequencing will be performed on fecal samples to assess alpha and beta diversity.The goal is to compare microbial community shifts and identify specific taxa changes associated with CDI. | Same retrospective collection period (2024-2026) |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
1 Day
참여 가능한 성별
전체
Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.
Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.
Group-Specific Criteria:
CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture.
Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms.
Healthy Controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI.
Consent/Authorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the institutional review board (IRB). However, any new information obtained directly from participants or their guardians (e.g., via questionnaires) requires explicit informed consent.
- Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
- Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing.
- Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.
Westlake University연구 대표 연락처
연락처: Liang Tao, PHD, 86-19817412816, [email protected]
연락처: Liqian Wang, 86-18768156110, [email protected]
1 1개국에 임상시험 장소
Zhejiang
Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310000, China
Liqian Wang, 연락처, 86-18768156110, [email protected]
모집중