- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joyce Wing Yan Mak
- Numéro de téléphone: +85226373260
- E-mail: wingyanmak@cuhk.edu.hk
Lieux d'étude
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Contact:
- Joyce Wing Yan Mak
- Numéro de téléphone: +85226373260
- E-mail: wingyanmak@cuhk.edu.hk
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Chercheur principal:
- Joyce Wing Yan Mak
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Micro- and nanoparticle abundance between subjects with Crohn's Disease and controls
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plastic-degrading gene [PDG] abundance between subjects with Crohn's Disease and controls.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joyce Wing Yan Mak, Chinese University of Hong Kong
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PLASTIC-CD
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