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

NCT06525558 | Not Yet Recruiting

• 1 other identifier: MATISSE
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

IBD

Keywords

Microplastics; Nanoplastics; Human Intestine; IBD

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline/Time zero

Secondary Outcomes (1)

• Evaluation of the possible correlation between the presence of the microplastics and nanoplastics in the humans bowel and Inflammatory Bowel Disease (IBD).

  Baseline/Time zero

Other Outcomes (1)

• Analysis of further characteristics of the study sample such as the metabolomics and proteomics characteristics and assessment of participants' daily plastic exposure.

  Baseline/Time zero

Study Arms (2)

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

Procedure: Intestinal resection

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

Procedure: Intestinal resection

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.

IBD Group; Non-IBD Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• Patients aged \< 18 years.
• Pregnant women.
• Patients who have not accepted informed consent.

Sponsors & Collaborators

• Pierpaolo Sileri: lead

Related Publications (12)

• Zhu L, Kang Y, Ma M, Wu Z, Zhang L, Hu R, Xu Q, Zhu J, Gu X, An L. Tissue accumulation of microplastics and potential health risks in human. Sci Total Environ. 2024 Mar 10;915:170004. doi: 10.1016/j.scitotenv.2024.170004. Epub 2024 Jan 12.

  PMID: 38220018 BACKGROUND

• Ibrahim YS, Tuan Anuar S, Azmi AA, Wan Mohd Khalik WMA, Lehata S, Hamzah SR, Ismail D, Ma ZF, Dzulkarnaen A, Zakaria Z, Mustaffa N, Tuan Sharif SE, Lee YY. Detection of microplastics in human colectomy specimens. JGH Open. 2020 Nov 21;5(1):116-121. doi: 10.1002/jgh3.12457. eCollection 2021 Jan.

  PMID: 33490620 BACKGROUND

• Yan Z, Liu Y, Zhang T, Zhang F, Ren H, Zhang Y. Analysis of Microplastics in Human Feces Reveals a Correlation between Fecal Microplastics and Inflammatory Bowel Disease Status. Environ Sci Technol. 2022 Jan 4;56(1):414-421. doi: 10.1021/acs.est.1c03924. Epub 2021 Dec 22.

  PMID: 34935363 BACKGROUND

• Geyer R, Jambeck JR, Law KL. Production, use, and fate of all plastics ever made. Sci Adv. 2017 Jul 19;3(7):e1700782. doi: 10.1126/sciadv.1700782. eCollection 2017 Jul.

  PMID: 28776036 BACKGROUND

• Galloway TS, Cole M, Lewis C. Interactions of microplastic debris throughout the marine ecosystem. Nat Ecol Evol. 2017 Apr 20;1(5):116. doi: 10.1038/s41559-017-0116.

  PMID: 28812686 BACKGROUND

• Renzi M, Blaskovic A. Litter & microplastics features in table salts from marine origin: Italian versus Croatian brands. Mar Pollut Bull. 2018 Oct;135:62-68. doi: 10.1016/j.marpolbul.2018.06.065. Epub 2018 Jul 6.

  PMID: 30301081 BACKGROUND

• Lai H, Liu X, Qu M. Nanoplastics and Human Health: Hazard Identification and Biointerface. Nanomaterials (Basel). 2022 Apr 11;12(8):1298. doi: 10.3390/nano12081298.

  PMID: 35458006 BACKGROUND

• Akhtar S, Pranay K, Kumari K. Personal protective equipment and micro-nano plastics: A review of an unavoidable interrelation for a global well-being hazard. Hyg Environ Health Adv. 2023 Jun;6:100055. doi: 10.1016/j.heha.2023.100055. Epub 2023 Apr 11.

  PMID: 37102160 BACKGROUND

• Cox KD, Covernton GA, Davies HL, Dower JF, Juanes F, Dudas SE. Human Consumption of Microplastics. Environ Sci Technol. 2019 Jun 18;53(12):7068-7074. doi: 10.1021/acs.est.9b01517. Epub 2019 Jun 5.

  PMID: 31184127 BACKGROUND

• Prata JC, da Costa JP, Lopes I, Duarte AC, Rocha-Santos T. Environmental exposure to microplastics: An overview on possible human health effects. Sci Total Environ. 2020 Feb 1;702:134455. doi: 10.1016/j.scitotenv.2019.134455. Epub 2019 Oct 4.

  PMID: 31733547 BACKGROUND

• Di Fiore C, Ishikawa Y, Wright SL. A review on methods for extracting and quantifying microplastic in biological tissues. J Hazard Mater. 2024 Feb 15;464:132991. doi: 10.1016/j.jhazmat.2023.132991. Epub 2023 Nov 10.

  PMID: 37979423 BACKGROUND

• Catarino AI, Thompson R, Sanderson W, Henry TB. Development and optimization of a standard method for extraction of microplastics in mussels by enzyme digestion of soft tissues. Environ Toxicol Chem. 2017 Apr;36(4):947-951. doi: 10.1002/etc.3608. Epub 2016 Oct 20.

  PMID: 27583696 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

This study does not add additional risks to patients since the intestinal resection is done during surgery according to standard clinical practice. The study sample will then be collected from the resected specimen and sent to the laboratory for proper storage and analysis.

Study Officials

• Pierpaolo Sileri, Prof.

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierpaolo Sileri, Prof.

CONTACT

0226439091; livolsi.emanuela@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: June 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 2, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share