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

ConditionIBD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPierpaolo Sileri

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Patients aged < 18 years.

Pregnant women.

Patients who have not accepted informed consent.

Trial design

Treatments tested in this trial

  • Intestinal resection

Treatment groups

102 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Pierpaolo Sileri

Lead sponsor

IRCCS Ospedale San Raffaele

Sponsor institution