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.
Patients who will undergo any type of bowel surgery due to any type of clinical condition, as established by normal clinical practice, where colon, ileum and/or rectum resection is involved.
Patients aged ≥ 18 years.
Patients who have read, understood, accepted, and signed the informed consent to the study.
Female patients within and outside of childbearing age (breastfeeding women can be included in the study)
Patients aged < 18 years.
Pregnant women.
Patients who have not accepted informed consent.
The study population includes patients 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. The participants will be male and female subjects, with age ≥ 18 years.
Case-control
Cross-sectional
Intestinal resection
Procedure/SurgeryThis study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.
Determination of the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum.
The variables for evaluating the primary objective: \- Monomer Type and characterization: * Type * Concentration
Evaluation of the possible correlation between the presence of the microplastics and nanoplastics in the humans bowel and Inflammatory Bowel Disease (IBD).
To determine this correlation, the participants will be divided in two groups: 1. IBD Group: Participants with IBD * Crohn disease (n=26) * Ulcerative Colitis (n=25) 2. Non IBD Group: Participants with other diseases that are not IBD (for example, tumor, rectal prolapse or diverticulitis) The data collected from the two groups will be compared and evaluated using appropriate statistical methods.
Analysis of further characteristics of the study sample such as the metabolomics and proteomics characteristics and assessment of participants' daily plastic exposure.
Since the presence of MNPs might influence the primary metabolomic pathways and lead to modifications in the proteomic profiling of tissues, metabolomics and proteomics analyses will be performed to comprehensively assess any possible alteration resulting from the presence of these particles. Furthermore, participants' daily plastic exposure will be assessed through the 10-minute questionnarie questions defined in the "Baseline Questionary" supporting document, related to their dietary habits.
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Pierpaolo Sileri
Lead sponsor
IRCCS Ospedale San Raffaele
Sponsor institution
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