- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089501
The Role of the Pregnane X Receptor (PXR) in Indole Signaling and Intestinal Permeability in Inflammatory Bowel Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
i) IBD patients
- Patients aged 18-65 with a diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis
- Willing and able to consent to participation in study
- In order to enroll in complete study, a clear indication for colonoscopy must be present. If colonoscopy is not indicated, patients may elect to participate by providing a stool specimen without undergoing colonoscopy.
- IBD patients with a clinical recommendation for small intestinal, colonic, or ileocolonic resection
ii) Control patients
Patients aged 18-65 with no diagnosis of inflammatory bowel disease being seen in the gastroenterology practice for the following indications
- Screening colonoscopy
- Iron deficiency anemia
- Rectal bleeding
- Esophageal reflux (colonoscopy only would be done if indicated for other reasons)
- Diarrhea (with exclusion of inflammatory bowel disease)
- Patients with no diagnosis of inflammatory bowel disease being seen in the surgery practice in whom small intestinal, colonic, or ileocolonic resection is recommended
iii) Pre-existing specimens from IBD patients
• Pre-existing specimens from the IBD patient tissue biobank of Dr. Gitit Tomer will also be analyzed. Only patient samples from patients who have provided informed written consent for use in future studies on the consent form for the pediatric IBD tissue biobank will be utilized in this study. Such patient specimens will be assigned a unique study identifier and the data will be stored as indicated below. There are currently 38 patients within this biobank, of which all 38 provided consent for use of the specimens in future studies. Specimens include both ileal and colonic biopsies, ileal and colonic fecal aspirates, and serum.
iv) Pediatric IBD patients
- Patients aged 0-22 with a diagnosis of Crohn's disease, ulcerative colitis, indeterminate colitis, or a family history of IBD
- Willing and able to consent to participation in study, or a parent or guardian provides written consent for participation
- In order to enroll in the complete study, a clear indication for colonoscopy and biopsy must be present. If colonoscopy is not indicated, patients may elect to participate by providing a stool specimen without undergoing colonoscopy.
- Pediatric IBD patients with a clinical recommendation for small intestinal, colonic, or ileocolonic resection
Exclusion Criteria:
- Unwilling or unable to provide consent
- Presence of comorbid systemic inflammatory disorders such as rheumatoid arthritis, sarcoidosis, psoriasis, multiple sclerosis, advanced or decompensated heart failure, cirrhosis, or morbid obesity (Body mass index (BMI) over 40)
- Irritable bowel syndrome
- Bowel obstruction
- Contraindication to colonoscopy or biopsies
- Cancer or malignancy within 12 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Inflammatory Bowel Disease (IBD)
Subjects will be asked to provide a stool sample (if no colonoscopy is to be performed) or if clinically indicated, a colonoscopy will be performed per standard medical routine.
During colonoscopy, stool will be collected for analysis and 3 additional biopsies will be taken each from the ileum and colon for research purposes.
Alternatively, subjects who are undergoing intestinal and/or colonic resection will provide stool prior to surgery and a portion of their pathology specimens will be used for research purposes following complete pathologic evaluation.
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Stool will be collected from subjects who have been diagnosed with IBD or whom small intestinal, colonic or ileocolonic and have signed consent for the control group.
Stool will be self-collected or through routine colonoscopy procedure.
3 additional biopsies (for research purposes) will be taken from patients who undergo colonoscopy as per standard of care
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Subjects not affected by IBD (Control Group)
Results of subjects with IBD will be compared to subjects in the control group.
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Stool will be collected from subjects who have been diagnosed with IBD or whom small intestinal, colonic or ileocolonic and have signed consent for the control group.
Stool will be self-collected or through routine colonoscopy procedure.
3 additional biopsies (for research purposes) will be taken from patients who undergo colonoscopy as per standard of care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of molecular studies in subjects with and without IBD
Time Frame: Up to 5 years
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We will measure and analyze RNA and protein levels of cytokines, junctional protein expression, PXR (pregnane X receptor) and TLRs (toll-like receptors) in tissues and perform intestinal permeability studies in subjects with and without IBD.
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Up to 5 years
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Assays for biofilm and phage
Time Frame: Up to 5 years
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Up to 5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sridhar Mani, MD, Albert Einstein College Of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-4465
- 3R01CA127231 (U.S. NIH Grant/Contract)
- 5R01CA161879 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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