Crohn's Disease (CD)NCT07630883
A Pilot Study: Micro and NanoPlastics in Association With Crohn's Disease
An observational study of Crohn's Disease (CD), run by Mak Wing Yan at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease (CD)
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2026to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- Control:
- Currently Pregnant
- Advanced terminal medical illness, e.g. terminal malignancies; end staged renal failure and liver failure
- Inability in giving consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong
Joyce Wing Yan Mak, +85226373260, wingyanmak@cuhk.edu.hk
Joyce Wing Yan Mak
About this study
Official 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
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.
Read the 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.
- Conditions
- Crohn's Disease (CD)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CD group | Crohn's disease patients with the score of Harvey-Bradshaw Index ≥ 5 | |
| Control group | Age- and sex-matched healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Cross-sectional when the stool, blood sample and the intestinal biopsy are collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mak Wing Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mak Wing Yan, Chinese University of Hong Kong
- Investigators
- Joyce Wing Yan Mak, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630883
- Sponsor's protocol ID
- PLASTIC-CD
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07630883
- Acronym / sponsor ID
- PLASTIC-CD
- Conditions
- Crohn's Disease (CD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mak Wing YanUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD group | – | –Crohn's disease patients with the score of Harvey-Bradshaw Index ≥ 5 |
| Control group | – | –Age- and sex-matched healthy individuals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Age 18-80 years
- Confirmed diagnosis of Crohn's disease (for cases)
- Ability to provide informed consent.
- Age 18-80 years old
- No history of major large bowel resection
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joyce Wing Yan Mak principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease (CD), run by Mak Wing Yan at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joyce Wing Yan Mak (+85226373260, wingyanmak@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.