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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07630883
Enrollment
90
Registered
2026-06-05
Start date
2026-06-15
Completion date
2031-12-31
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease (CD)

Brief summary

Micro and nanoplastics (MNPs) are environmental contaminants found in food and water. Recent evidence suggests these particles may be linked to intestinal inflammation and changes in gut bacteria, which are key features of Crohn's Disease (CD). This study aims to investigate if patients with Crohn's Disease have a reduced ability to clear these plastic particles and how this affects their immune system and intestinal health.

Detailed description

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.

Interventions

None listed

Sponsors

Mak Wing Yan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Micro- and nanoparticle abundance between subjects with Crohn's Disease and controlsCross-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.

Secondary

MeasureTime frameDescription
Plastic-degrading gene [PDG] abundance between subjects with Crohn's Disease and controls.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.

Countries

Hong Kong

Contacts

CONTACTJoyce Wing Yan Mak
wingyanmak@cuhk.edu.hk+85226373260
PRINCIPAL_INVESTIGATORJoyce Wing Yan Mak

Chinese University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026