Crohn DiseaseMAP-IBDNCT07141238
Microplastic Analysis in Pediatric Inflammatory Bowel Disease
An observational study of Crohn Disease and Pediatric Inflammatory Bowel Diseases, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The goal of this observational study is to measure and compare the presence of microplastics in children with inflammatory bowel disease (IBD) and children without IBD. The main questions it aims to answer are: Are microplastics detectable in different biological samples from children? Are there differences in… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Crohn Disease, Pediatric Inflammatory Bowel Diseases, Ulcerative Colitis (UC)
- What is being tested?
- Environmental microplastic exposure
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jun 2025to Jun 2026
- How long will I take part?
- 1 Day
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing endoscopy at a tertiary care academic hospital. The study includes children with confirmed inflammatory bowel disease and children undergoing endoscopy for other indications as controls.
Who may be able to join
- Age <18 years
- Undergoing clinically indicated gastrointestinal endoscopy
- For IBD group: confirmed diagnosis of Crohn's disease or ulcerative colitis
- For control group: no current or past diagnosis of IBD
Who cannot join
- Age 18 years or older
- Lack of informed consent from legal guardian
- Lack of written assent from the participant if age ≥13 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk, Department of Pediatrics, Gastroenterology, Allergolgy and Nutrition
Gdansk, 80-803
Dominika Marszk, MD, 609619101, dsierdzinska@gmail.com
Michał Brzeziński, Professor
About this study
Official title: Analysis of Microplastics in Pediatric Inflammatory Bowel Disease Using Raman Spectroscopy: A Multi-Matrix Study
The goal of this observational study is to measure and compare the presence of microplastics in children with inflammatory bowel disease (IBD) and children without IBD. The main questions it aims to answer are:
Are microplastics detectable in different biological samples from children? Are there differences in microplastic burden between children with and without IBD?
Read more
Researchers will collect biological samples including: intestinal tissue (from routine endoscopy), stool, urine, blood.
Raman spectroscopy will be used to detect and characterize microplastics in each sample type. Participants will not receive any medication or intervention as part of this study. All samples will be collected during standard clinical procedures.
- Conditions
- Crohn Disease, Pediatric Inflammatory Bowel Diseases, Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
- Being tested
- Environmental microplastic exposure
- Keywords
- Microplastics, Pediatric Inflammatory Bowel Disease, Raman Spectroscopy, Environmental exposure, Ulcerative Colitis, Crohn's Disease
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental microplastic exposureOther
Exposure to environmental microplastics measured by their presence in intestinal tissue, blood, urine, and stool using Raman spectroscopy. This study does not assign any exposure or treatment; it investigates the existing presence of microplastics as an environmental factor of interest.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric IBD group | Children diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis) undergoing clinically indicated endoscopy. Biological samples, including intestinal biopsies, stool, urine, and blood, will be collected and analyzed for microplastic content using Raman spectroscopy. Receives: Other: Environmental microplastic exposure | |
| Control group | Children without a diagnosis of IBD undergoing endoscopy for non-inflammatory indications (e.g., polyps, anemia). Biological samples, including intestinal biopsies, stool, urine, and blood, will be collected and analyzed for microplastic content using Raman spectroscopy. Receives: Other: Environmental microplastic exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and concentration of microplastics in intestinal tissue samples
Quantification of microplastics (number of particles per gram of tissue) detected using Raman spectroscopy in intestinal mucosal biopsies collected during clinically indicated endoscopy.
Measured: Day of endoscopy (Baseline)
Secondary outcomes (1)
Comparison of microplastic burden between children with IBD and controls
Assessment of differences in all biological matrices (tissue, stool, blood, urine) between children with inflammatory bowel disease and controls
Measured: Baseline (Day of sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start15 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141238
- Sponsor's protocol ID
- MAP-IBD-2025
- Acronym
- MAP-IBD
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Microplastics in Pediatric Inflammatory Bowel Disease Using Raman Spectroscopy: A Multi-Matrix Study
- ClinicalTrials.gov ID
- NCT07141238
- Acronym / sponsor ID
- MAP-IBD / MAP-IBD-2025
- Conditions
- Crohn Disease, Pediatric Inflammatory Bowel Diseases, Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)
- Keywords
- Microplastics, Pediatric Inflammatory Bowel Disease, Raman Spectroscopy, Environmental exposure, Ulcerative Colitis, Crohn's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Aug 2025 (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.
The goal of this observational study is to measure and compare the presence of microplastics in children with inflammatory bowel disease (IBD) and children without IBD. The main questions it aims to answer are:
Are microplastics detectable in different biological samples from children? Are there differences in microplastic burden between children with and without IBD?
Researchers will collect biological samples including: intestinal tissue (from routine endoscopy), stool, urine, blood.
Raman spectroscopy will be used to detect and characterize microplastics in each sample type. Participants will not receive any medication or intervention as part of this study. All samples will be collected during standard clinical procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric IBD group | – | Other: Environmental microplastic exposureChildren diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis) undergoing clinically indicated endoscopy. Biological samples, including intestinal biopsies, stool, urine, and blood, will be collected and analyzed for microplastic content using Raman spectroscopy. |
| Control group | – | Other: Environmental microplastic exposureChildren without a diagnosis of IBD undergoing endoscopy for non-inflammatory indications (e.g., polyps, anemia). Biological samples, including intestinal biopsies, stool, urine, and blood, will be collected and analyzed for microplastic content using Raman spectroscopy. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing endoscopy at a tertiary care academic hospital. The study includes children with confirmed inflammatory bowel disease and children undergoing endoscopy for other indications as controls.
Key inclusion criteria (4 listed)
- Age <18 years
- Undergoing clinically indicated gastrointestinal endoscopy
- For IBD group: confirmed diagnosis of Crohn's disease or ulcerative colitis
- For control group: no current or past diagnosis of IBD
Key exclusion criteria (3 listed)
- Age 18 years or older
- Lack of informed consent from legal guardian
- Lack of written assent from the participant if age ≥13 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental microplastic exposureExposure to environmental microplastics measured by their presence in intestinal tissue, blood, urine, and stool using Raman spectroscopy. This study does not assign any exposure or treatment; it investigates the existing presence of microplastics as an environmental factor of interest. | Other | Control group, Pediatric IBD group |
Primary outcome
Presence and concentration of microplastics in intestinal tissue samples
Time frame: Day of endoscopy (Baseline)
Quantification of microplastics (number of particles per gram of tissue) detected using Raman spectroscopy in intestinal mucosal biopsies collected during clinically indicated endoscopy.
1 secondary outcome
Comparison of microplastic burden between children with IBD and controls
Time frame: Baseline (Day of sample collection)
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 30 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Disease and Pediatric Inflammatory Bowel Diseases, run by Medical University of Gdansk at 1 site in Poland.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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 Poland. 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 Dominika Marszk, MD (+48609619101, dsierdzinska@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and concentration of microplastics in intestinal tissue samples (time frame: Day of endoscopy (Baseline)). 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 30 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.