The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)
NCT ID: NCT06525558
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
102 participants
OBSERVATIONAL
2025-06-30
2025-12-30
Brief Summary
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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.
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Detailed Description
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This study is a cross-sectional, single-center, non-profit, observational study in which filling out, una-tantum, the daily plastic exposure 10-minute questionnaire is the only additional procedure. Adult 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, will be included (n=102). Participants will be divided in two groups, Group IBD (n=51) and Group Non IBD (n=102).
This study does not add additional clinical practices or controls to the participants and there are not follow up visits programmed. Furthermore, this study does not add additional risks to patients since the intestinal resection is done during surgery according to standard clinical practice.
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 and the study object is to determine the presence, composition, and potential health implications of microplastics and nanoplastics in the human ileum, colon, and rectum. Focusing on whether the presence of these particles correlates with intestinal inflammatory processes.
For this purpose, the primary objective of this study is to determine the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum. The secondary objective is to evaluate if there is correlation between the presence of the microplastics and nanoplastics in the humans bowel and Inflammatory Bowel Disease (IBD). Finally, the exploratory objectives are to analyze further characteristics of the study sample such as the metabolomics and proteomics characteristics and to assess participants' daily plastic exposure.
The study will have a total duration of 15 months and includes 9 months of enrollment and 6 months for laboratory analysis. All the collected samples will be analyzed in vitro by the following methods:
* MNPs presence determination and characterization
* Metabolomics
* Proteomics
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
Intestinal resection
This study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.
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
Intestinal resection
This study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.
Interventions
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Intestinal resection
This study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Pregnant women.
* Patients who have not accepted informed consent.
18 Years
ALL
No
Sponsors
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Pierpaolo Sileri
OTHER
Responsible Party
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Pierpaolo Sileri
Professor
Principal Investigators
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Pierpaolo Sileri, Prof.
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MATISSE
Identifier Type: -
Identifier Source: org_study_id
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