Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-05 @ 2:07 PM
Study NCT ID:
NCT06525558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-02
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Analysis of further characteristics of the study sample such as the metabolomics and proteomics characteristics and assessment of participants' daily plastic exposure.", 'timeFrame': 'Baseline/Time zero', 'description': '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.\n\nFurthermore, 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.'}], 'primaryOutcomes': [{'measure': 'Determination of the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum.', 'timeFrame': 'Baseline/Time zero', 'description': 'The variables for evaluating the primary objective:\n\n\\- Monomer Type and characterization:\n\n* Type\n* Concentration'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the possible correlation between the presence of the microplastics and nanoplastics in the humans bowel and Inflammatory Bowel Disease (IBD).', 'timeFrame': 'Baseline/Time zero', 'description': 'To determine this correlation, the participants will be divided in two groups:\n\n1. IBD Group: Participants with IBD\n\n * Crohn disease (n=26)\n * Ulcerative Colitis (n=25)\n2. Non IBD Group: Participants with other diseases that are not IBD (for example, tumor, rectal prolapse or diverticulitis)\n\nThe data collected from the two groups will be compared and evaluated using appropriate statistical methods.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microplastics', 'Nanoplastics', 'Human Intestine', 'IBD'], 'conditions': ['IBD']}, 'referencesModule': {'references': [{'pmid': '38220018', 'type': 'BACKGROUND', 'citation': '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': '33490620', 'type': 'BACKGROUND', 'citation': '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': '34935363', 'type': 'BACKGROUND', 'citation': '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': '28776036', 'type': 'BACKGROUND', 'citation': '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': '28812686', 'type': 'BACKGROUND', 'citation': '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': '30301081', 'type': 'BACKGROUND', 'citation': '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': '35458006', 'type': 'BACKGROUND', 'citation': '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': '37102160', 'type': 'BACKGROUND', 'citation': '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': '31184127', 'type': 'BACKGROUND', 'citation': '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': '31733547', 'type': 'BACKGROUND', 'citation': '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': '37979423', 'type': 'BACKGROUND', 'citation': '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': '27583696', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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).\n\nThis 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.", 'detailedDescription': "Based on recent studies, it is hypothesized that MNPs are present in the human's ileum, colon, and rectum and that this presence may have a correlation with Inflammatory Bowel Disease (IBD).\n\nThis 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).\n\nThis 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.\n\nThe 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.\n\nFor 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.\n\nThe 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:\n\n* MNPs presence determination and characterization\n* Metabolomics\n* Proteomics"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Patients aged ≥ 18 years.\n* Patients who have read, understood, accepted, and signed the informed consent to the study.\n* Female patients within and outside of childbearing age (breastfeeding women can be included in the study)\n\nExclusion Criteria:\n\n* Patients aged \\< 18 years.\n* Pregnant women.\n* Patients who have not accepted informed consent.'}, 'identificationModule': {'nctId': 'NCT06525558', 'acronym': 'MATISSE', 'briefTitle': 'The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Ospedale San Raffaele'}, 'officialTitle': 'The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD): A Cross-sectional Observational Study', 'orgStudyIdInfo': {'id': 'MATISSE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD Group', 'description': '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', 'interventionNames': ['Procedure: Intestinal resection']}, {'label': 'Non-IBD Group', 'description': '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', 'interventionNames': ['Procedure: Intestinal resection']}], 'interventions': [{'name': 'Intestinal resection', 'type': 'PROCEDURE', 'description': 'This study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.', 'armGroupLabels': ['IBD Group', 'Non-IBD Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pierpaolo Sileri, Prof.', 'role': 'CONTACT', 'email': 'livolsi.emanuela@hsr.it', 'phone': '0226439091'}], 'overallOfficials': [{'name': 'Pierpaolo Sileri, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierpaolo Sileri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pierpaolo Sileri', 'investigatorAffiliation': 'IRCCS Ospedale San Raffaele'}}}}