Microplastic Analysis in Pediatric Inflammatory Bowel Disease

NCT07141238 | Recruiting

• 1 other identifier: MAP-IBD-2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

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.

  Day of endoscopy (Baseline)

Secondary Outcomes (1)

• Comparison of microplastic burden between children with IBD and controls

  Baseline (Day of sample collection)

Study Arms (2)

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.

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.

Other: Environmental microplastic exposure

Interventions

Environmental microplastic exposure OTHER

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.

Control group; Pediatric IBD group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Age 18 years or older
• Lack of informed consent from legal guardian
• Lack of written assent from the participant if age ≥13 years

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk, Department of Pediatrics, Gastroenterology, Allergolgy and Nutrition

Gdansk, 80-803, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Intestinal tissue biopsies, stool samples, urine samples, blood samples

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Dominika Marszk, MD

CONTACT

+48609619101; dsierdzinska@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 26, 2025
• Study Start: June 15, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)