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To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis in human gastrointestinal diseases.
The purpose of the proposed research is to collect tissue, blood and fecal samples from patients undergoing standard of care for their gastrointestinal disease, including Inflammatory Bowel Disease (IBD), and Colorectal Cancer (CRC). Tissue and blood samples will be obtained during procedures that are part of normal treatment, including blood and fecal collection, surgical resection, and biopsy collection. Samples will be obtained from consenting patients at Seton Dell Medical Center at the University of Texas (SDMCUT), or other relevant facilities (see section 6.i below), and only tissue not required for histopathological analysis will be collected. Initially, the focus will be on IBD, and CRC, where there are extensive previous studies to draw from. The collected samples of the proposed study will be used to establish biomimetic human organ-on-a-chip platforms by leveraging microfluidic tissue culture technology. Another focus of the research will be study the human intestinal microbiome that is highly associated with the pathogenesis of human gastrointestinal diseases. The investigators have developed the microchip technology to mimic the structure and physiological function of human intestine by integrating tools developed in a microfluidic device, tissue engineering, and clinical microbiology, using intestinal cell lines. To recreate more reliable intestinal disease models and to further investigate the host-gut microbiome interactions in these experimental platforms, the investigators are transitioning to use human clinical samples. The investigators will use tissue biopsies to culture human intestinal cells including epithelium, endothelium, connective tissues on-chip. Blood samples will also obtained to isolate peripheral blood mononuclear cells (PBMC) that represent mixed population of white blood cells (WBC). Isolated WBCs will be co-cultured with intestinal cells. Any potential application of microbiome-related therapies such as fecal microbiota transplantation (FMT) will also be further investigated.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
The University of Texas
Austin, Texas, United States
Start Date
July 13, 2018
Primary Completion Date
July 1, 2022
Completion Date
July 1, 2022
Last Updated
June 16, 2021
300
ESTIMATED participants
no intervention will be given to patients.
OTHER
Lead Sponsor
University of Texas at Austin
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06579443