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

NCT07630883 | Not Yet Recruiting

• 1 other identifier: PLASTIC-CD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease (CD)

Outcome Measures

Primary Outcomes (1)

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

  Blood sample and intestinal biopsy specimens will be collected to perform micro and nanoplastics quantification.

  Cross-sectional when the blood sample and the intestinal biopsy are collected.

Secondary Outcomes (1)

• 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.

Study Arms (2)

CD group

Crohn's disease patients with the score of Harvey-Bradshaw Index ≥ 5

Control group

Age- and sex-matched healthy individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be identified at the Department of Medicine and Therapeutics of the Prince of Wales Hospital, or by personal referral from staff.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mak Wing Yan: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study samples left from this study will be stored for 15 years for future study or analyses after completion of the study.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Joyce Wing Yan Mak

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce Wing Yan Mak

CONTACT

+85226373260; wingyanmak@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

HK (1)