- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Joyce Wing Yan Mak
- Telefonnummer: +85226373260
- E-post: wingyanmak@cuhk.edu.hk
Studiesteder
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Ta kontakt med:
- Joyce Wing Yan Mak
- Telefonnummer: +85226373260
- E-post: wingyanmak@cuhk.edu.hk
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Hovedetterforsker:
- Joyce Wing Yan Mak
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Micro- and nanoparticle abundance between subjects with Crohn's Disease and controls
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Plastic-degrading gene [PDG] abundance between subjects with Crohn's Disease and controls.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Joyce Wing Yan Mak, Chinese University of Hong Kong
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PLASTIC-CD
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