Microplastic Analysis in Pediatric Inflammatory Bowel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorMedical University of Gdansk

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age 18 years or older

Lack of informed consent from legal guardian

Lack of written assent from the participant if age ≥13 years

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Environmental microplastic exposure

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Pediatric IBD group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Time frame
Baseline (Day of sample collection)

Other outcomes

Sponsors and contacts

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