- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171872
Gene Expression in Inflammatory Bowel Disease
Study Overview
Status
Conditions
Detailed Description
Progress has been made in recent years in understanding the pathological mechanisms of IBD, particularly in the search of IBD susceptibility genes. However, due to the extreme complexity of the diseases, there is still a long way ahead in elucidating detailed molecular mechanisms of IBD pathogenesis and identifying more effective therapeutic targets. Therefore, it is the goal of this research study to discover genetic, microbial, gene expression and serological factors involved in the pathogenesis of IBD which may pave the way for the identification of more effective therapeutic targets.
The specific aims for these objectives are as follows:
AIM 1: Identify proteins that are changed in expression and post-translational modification in the intestinal mucosa of patients with active UC or CD compared to i) uninvolved intestinal mucosa from the same patients, ii) normal intestinal mucosa in control subjects, and iii) infectious/Inflammatory colitis (C. difficile colitis).
AIM 2: Identify changes in the expression of intestinal membrane transporters for Na absorption and Cl secretion, including NHE3, in the intestinal mucosa of patients with active UC or CD compared to i) uninvolved intestinal mucosa from the same patients, ii) normal intestinal mucosa in control subjects, and and iii) infectious/Inflammatory colitis (C. difficile colitis). The targeted screening will also include several intestinal epithelial brush border-associated PDZ-containing proteins that have been recently shown to regulate trafficking and activity of membrane transporters.
AIM 3: Enteroid Sub-study - To compare the physiologic regulation of Na absorption, Cl secretion, protein secretion and other intestinal physiologic processes in IBD cases, other infectious colitis cases and healthy controls as these processes are often altered with disease activities. The processes will be studied through the development of self-propagating culture models called organoids or enteroids. The culture models are developed from biopsy specimens taken from the upper small intestine, including duodenum and jejunum , lower small intestine (ileum) and proximal and distal colon and used to grow organoids/enteroids. These are mini-intestines that have the entire crypt villus axes which grow in culture and can be kept alive indefinitely in culture.
AIM 4: Mechanism of Intestinal Inflammation Sub-study - To understand the mechanisms involved in the recurrence of inflammation following ileal resection surgery for Crohn's disease (CD). Reasons for recurrence are currently unknown but are believed to be caused by an interaction of genetic, immune and microbial features. Information gained from this study will be used to build a predictive model to identify those patients at greater risk of rapid recurrence, and will aid physicians in tailoring follow-up treatments.
AIM 5: UC Demarcation Sub-study - To gain further understanding of the mechanisms involved in the susceptibility to and flare of inflammation in UC patients. Blood, stool, urine, saliva, lavage and tissue samples from UC patients will be used to help study the genetic, microbial, metabolic, and immune factors involved in the remission and flare of disease. Information gained from this study will also be used to build a predictive model of which patients are at greater risk of disease flare, and which are less likely to do so, allowing physicians to tailor follow-up treatments accordingly.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Individuals who are to undergo upper or lower gastrointestinal endoscopies or a surgical resection as part of their normal medical care and deemed necessary by their physicians.
Patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals can contact us by phone, mail or email after hearing about our study.
Description
Inclusion Criteria:
- All persons, regardless of IBD affection status, greater than 7 years of age undergoing upper or lower endoscopy or bowel resection
Exclusion Criteria:
- Persons with bleeding tendencies
- Persons on anti-coagulation therapy or who will be place on anti-coagulation therapy following the planned endoscopy procedures
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Unaffected
Individuals who do not have IBD
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Affected
Individuals who have IBD
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Florin Selaru, M.D., Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00038329
- U01DK062431 (U.S. NIH Grant/Contract)
- R24DK099803 (U.S. NIH Grant/Contract)
- P01AI125181 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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