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NCT Number: NCT07630883

A Pilot Study: Micro and NanoPlastics in Association With Crohn's Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

Location contact

Joyce Wing Yan Mak

CONTACT

[email protected]

+85226373260

Joyce Wing Yan Mak

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Micro- and nanoparticle abundance between subjects with Crohn's Disease and controls

    Time frame: Cross-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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joyce Wing Yan Mak

CONTACT

[email protected]

+85226373260

Sponsors and collaborators

Lead sponsor

Mak Wing Yan

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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