Status:
COMPLETED
The Role of the Pregnane X Receptor (PXR) in Indole Signaling and Intestinal Permeability in Inflammatory Bowel Disease
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
Up to 65 years
Brief Summary
The goal of this study is to better understand the mechanisms responsible for the development of and the severity of Inflammatory Bowel Disease (IBD), such as Crohn's Disease and Ulcerative Colitis, w...
Detailed Description
Based on promising preliminary data, the study will characterize the claim that PXR signaling serves as a key mechanistic link between the host environment and the innate immune system in the gut. It ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 2 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04089501
Start Date
February 25 2015
End Date
May 2 2019
Last Update
September 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montefiore Medical Center
The Bronx, New York, United States, 10461