- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07630883
A Pilot Study: Micro and NanoPlastics in Association With Crohn's Disease
Integrated Multi-phase Investigation of Role of Micro and NanoPlastics in Association With Crohn's Disease: Targeting Microbiome, Immunity, and Barrier Dysfunction: A Pilot Study
연구 개요
상태
정황
상세 설명
Micro and nanoplastics may influence Crohn's Disease activity and gut health by impairing microplastic-degrading capacity of the gut microbiome due to the decreased plastic-degrading genes (PDGs) encoding enzymes (e.g., esterases, cutinases, PETases, laccases). Persistent Microplastics (MPs) drive worsening dysbiosis, which in turn amplifies immune activation, evidenced by increase in pro-inflammatory cytokines and disrupts intestinal barrier integrity. The resulting barrier leakage facilitates further MPs translocation, perpetuating disease exacerbation. This study is looking at the effects of micro- and nanoplastics (MNPs) on the gut microbiome, immune function, and intestinal barrier function.
Patients with Crohn's disease (CD) and healthy controls will be recruited during routine clinic visit or on the day of their scheduled colonoscopy following written informed consent.
In this study, demographic data (age, sex, smoking and alcohol status), as well as past medical and surgical history and current medications will be collected. A questionnaire focused on plastic-packaged foods in daily lives will also be administered.
All recruited subjects will have biopsies taken at their scheduled colonoscopy within 4 weeks of recruitment. Stool and blood will be collected cross-sectionally at recruitment.The fecal calprotectin tests and the Harvey-Bradshaw Index (HBI) will be used to assess the severity.
The flow cytometry to quantify cell populations; multiplex ELISA to determine levels of pro- and anti-inflammatory cytokines and a phagocytosis assay will be used for the scientific outcome measurements of the samples collected.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Joyce Wing Yan Mak
- 전화번호: +85226373260
- 이메일: wingyanmak@cuhk.edu.hk
연구 장소
-
-
-
Hong Kong, 홍콩
- Prince of Wales Hospital
-
연락하다:
- Joyce Wing Yan Mak
- 전화번호: +85226373260
- 이메일: wingyanmak@cuhk.edu.hk
-
수석 연구원:
- Joyce Wing Yan Mak
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Cases:
- Age 18-80 years
- Confirmed diagnosis of Crohn's disease (for cases)
- Ability to provide informed consent.
Control:
- Age 18-80 years old
- No history of major large bowel resection
- Ability to provide informed consent.
Exclusion Criteria:
Cases:
- Antibiotic/probiotic use within 4 weeks
- History of gastrointestinal malignancy
- Presence of stoma
- Currently Pregnant
- Advanced terminal medical illness, e.g. terminal malignancies; end staged renal failure and liver failure
Control:
- Currently Pregnant
- Advanced terminal medical illness, e.g. terminal malignancies; end staged renal failure and liver failure
- Inability in giving consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
CD group
Crohn's disease patients with the score of Harvey-Bradshaw Index ≥ 5
|
|
Control group
Age- and sex-matched healthy individuals
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Micro- and nanoparticle abundance between subjects with Crohn's Disease and controls
기간: Cross-sectional when the blood sample and the intestinal biopsy are collected.
|
Blood sample and intestinal biopsy specimens will be collected to perform micro and nanoplastics quantification.
|
Cross-sectional when the blood sample and the intestinal biopsy are collected.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plastic-degrading gene [PDG] abundance between subjects with Crohn's Disease and controls.
기간: Cross-sectional when the stool, blood sample and the intestinal biopsy are collected.
|
Blood and stool samples, as well as intestinal biopsy specimens will be collected to perform fecal DNA extraction, metagenomic sequencing and Plastic-Degrading Genes (PDG) analysis.
|
Cross-sectional when the stool, blood sample and the intestinal biopsy are collected.
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Joyce Wing Yan Mak, Chinese University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .