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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Joyce Wing Yan Mak
- 電話番号：+85226373260
- メール：wingyanmak@cuhk.edu.hk
研究場所
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Hong Kong、香港
- Prince of Wales Hospital
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コンタクト：
- Joyce Wing Yan Mak
- 電話番号：+85226373260
- メール：wingyanmak@cuhk.edu.hk
-
主任研究者：
- Joyce Wing Yan Mak
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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CD group
Crohn's disease patients with the score of Harvey-Bradshaw Index ≥ 5
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Control group
Age- and sex-matched healthy individuals
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Micro- and nanoparticle abundance between subjects with Crohn's Disease and controls
時間枠：Cross-sectional when the blood sample and the intestinal biopsy are collected.
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Blood sample and intestinal biopsy specimens will be collected to perform micro and nanoplastics quantification.
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Cross-sectional when the blood sample and the intestinal biopsy are collected.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Plastic-degrading gene [PDG] abundance between subjects with Crohn's Disease and controls.
時間枠：Cross-sectional when the stool, blood sample and the intestinal biopsy are collected.
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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.
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Cross-sectional when the stool, blood sample and the intestinal biopsy are collected.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Joyce Wing Yan Mak、Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。