The Role of the Pregnane X Receptor (PXR) in Indole Signaling and Intestinal Permeability in Inflammatory Bowel Disease

NCT04089501 | Completed DMC

• 3 other identifiers: 2015-44653R01CA1272315R01CA161879
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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, which cause inflammation of the gut as well as potentially affecting other areas of the body

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

• Analysis of molecular studies in subjects with and without IBD

  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.

  Up to 5 years

• Assays for biofilm and phage

  Up to 5 years

Study Arms (2)

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.

Diagnostic Test: Stool collection; Diagnostic Test: Biopsy collection

Subjects not affected by IBD (Control Group)

Results of subjects with IBD will be compared to subjects in the control group.

Diagnostic Test: Stool collection; Diagnostic Test: Biopsy collection

Interventions

Stool collection DIAGNOSTIC_TEST

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.

Inflammatory Bowel Disease (IBD); Subjects not affected by IBD (Control Group)

Biopsy collection DIAGNOSTIC_TEST

3 additional biopsies (for research purposes) will be taken from patients who undergo colonoscopy as per standard of care

Inflammatory Bowel Disease (IBD); Subjects not affected by IBD (Control Group)

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects belonging to the target population, (i.e., Diagnosed with IBD, specifically Crohn's disease, ulcerative colitis, or indeterminate colitis and patients with no diagnosis of IBD in whom small intestinal, colonic, or ileocolonic resection is recommended.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue, Stool

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Sridhar Mani, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: February 25, 2015
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)