IBDMATISSENCT06525558
The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)
An observational study of IBD, run by Pierpaolo Sileri.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD
- What is being tested?
- Intestinal resection
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients aged < 18 years.
- Pregnant women.
- Patients who have not accepted informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the detailed description
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).
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
- IBD
- Being tested
- Intestinal resection
- Keywords
- Microplastics, Nanoplastics, Human Intestine, IBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal resectionProcedure or surgery
This study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Intestinal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
To determine this correlation, the participants will be divided in two groups:
- IBD Group: Participants with IBD
- Crohn disease (n=26)
- Ulcerative Colitis (n=25)
- 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.
Measured: Baseline/Time zero
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study startJun 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierpaolo Sileri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierpaolo Sileri, IRCCS Ospedale San Raffaele
- Investigators
- Pierpaolo Sileri, Prof., Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525558
- Sponsor's protocol ID
- MATISSE
- Acronym
- MATISSE
- Status last verified
- Oct 2024
- First submitted
- 24 Jul 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38220018Ibrahim 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.
PubMed 33490620Yan 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.
PubMed 34935363Geyer 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.
PubMed 28776036Galloway 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.
PubMed 28812686Renzi 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.
PubMed 30301081Lai 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.
PubMed 35458006Akhtar 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.
PubMed 37102160Cox 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.
PubMed 31184127Prata 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.
PubMed 31733547Di 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.
PubMed 37979423Catarino 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.
PubMed 27583696
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06525558
- Acronym / sponsor ID
- MATISSE / MATISSE
- Conditions
- IBD
- Keywords
- Microplastics, Nanoplastics, Human Intestine, IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Pierpaolo SileriUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD Group | – | Procedure: Intestinal resectionPatients 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 |
| Non-IBD Group | – | Procedure: Intestinal resectionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients aged < 18 years.
- Pregnant women.
- Patients who have not accepted informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal resectionThis study does not add additional risks for patients as the resected specimen is collected during the surgery in accordance with standard clinical practice. | Procedure or surgery | IBD Group, Non-IBD Group |
Primary outcome
Determination of the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum.
Time frame: Baseline/Time zero
The variables for evaluating the primary objective: - Monomer Type and characterization: * Type * Concentration
1 secondary outcome
Evaluation of the possible correlation between the presence of the microplastics and nanoplastics in the humans bowel and Inflammatory Bowel Disease (IBD).
Time frame: Baseline/Time zero
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 38220018Zhu 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.
- Background: PubMed 33490620Ibrahim 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.
- Background: PubMed 34935363Yan 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.
- Background: PubMed 28776036Geyer 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.
- Background: PubMed 28812686Galloway 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.
- Background: PubMed 30301081Renzi 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.
- Background: PubMed 35458006Lai 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.
- Background: PubMed 37102160Akhtar 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.
- Background: PubMed 31184127Cox 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.
- Background: PubMed 31733547Prata 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.
- Background: PubMed 37979423Di 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.
- Background: PubMed 27583696Catarino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierpaolo Sileri, Prof. principal investigator
IRCCS Ospedale San Raffaele
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Pierpaolo Sileri.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierpaolo Sileri, Prof. (0226439091, livolsi.emanuela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the presence of microplastics and nanoplastics in the humans ileum, colon, and rectum. (time frame: Baseline/Time zero). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06525558, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.