Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
The Presence of Microplastics and Nanoplastics in the Humans Ileum Colon and Rectum and Their Relation With Inflammatory Bowel Disease IBD
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATISSE
Brief Summary:
Based on recent studies it is hypothesized that microplastics and nanoplastics MNPs are present in humans 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
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 humans 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 andor rectum will be included n102 Participants will be divided in two groups Group IBD n51 and Group Non IBD n102
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 andor 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
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 andor rectum will be included n102 Participants will be divided in two groups Group IBD n51 and Group Non IBD n102
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None