The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)

Sponsor
Pierpaolo Sileri
Study ID
NCT06525558
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intestinal resection — PROCEDURE
    This study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.

Study Details

Based on recent studies it is hypothesized that microplastics and nanoplastics (MNPs) are present in human's ileum, colon, and rectum and that their presence may have a correlation with Inflammatory Bowel Disease (IBD). This study is a cross-sectional, single-center, non-profit observational study. The main objectives are to define in vitro the presence of MNPs in the humans ileum, colon, and rectum and to evaluate if there is a correlation between this presence and IBD. In vitro metabolomics and proteomics analyses of the study sample and the assessment of participants' daily plastic exposure are considered exploratory objectives. For this purpose, a total of 102 patients undergoing a surgery where intestinal resection is included, will be enrolled.

Key Dates

Start date
Jun 30, 2025
Status verified
Oct 2024
Primary completion
Sep 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
102 participants (estimated)

Arms

  • Arm: IBD Group
    Patients with IBD disease (Crohn disease and Ulcerative Colitis) who will be subjected, as established by normal clinical practice, to any type of bowel surgery that involves resection of colon, ileum and/or rectum
  • Arm: Non-IBD Group
    Patients with other diseases that are not IBD (for example, tumor, rectal prolapse or diverticulitis) who will be subjected, as established by normal clinical practice, to any type of bowel surgery that involves resection of colon, ileum and/or rectum

Primary Outcome Measure

Determination of the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum. [ Time Frame: Baseline/Time zero ]

Central Contacts

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