- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Joyce Wing Yan Mak
- Telefonnummer: +85226373260
- E-Mail: wingyanmak@cuhk.edu.hk
Studienorte
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Hong Kong, Hongkong
- Prince of Wales Hospital
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Kontakt:
- Joyce Wing Yan Mak
- Telefonnummer: +85226373260
- E-Mail: wingyanmak@cuhk.edu.hk
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Hauptermittler:
- Joyce Wing Yan Mak
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Micro- and nanoparticle abundance between subjects with Crohn's Disease and controls
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Plastic-degrading gene [PDG] abundance between subjects with Crohn's Disease and controls.
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Joyce Wing Yan Mak, Chinese University of Hong Kong
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PLASTIC-CD
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