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

NCT ID: NCT04089501

Last Updated: 2019-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-25

Study Completion Date

2019-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 is widely believed that one cause of IBD stems from abnormal sensing of commensal bacteria. The research will shed light on the molecular mechanisms used by gut barrier epithelial cells in sensing commensals and regulating inflammatory responses in the gut. This will provide a new mechanism towards which more mechanisms derived probiotics could be used to abrogate intestinal inflammation. It is hoped that these agents would eventually serve as non-toxic alternatives or adjuncts to currently available therapeutics for IBD. The research protocol will involve the collection of feces, either by self-collection or through colonoscopic washing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Stool collection

Intervention Type 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.

Biopsy collection

Intervention Type DIAGNOSTIC_TEST

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

Subjects not affected by IBD (Control Group)

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

Stool collection

Intervention Type 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.

Biopsy collection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stool collection

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.

Intervention Type DIAGNOSTIC_TEST

Biopsy collection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sridhar Mani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sridhar Mani, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3R01CA127231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01CA161879

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-4465

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.