Inflammatory Bowel DiseasesNCT04089501
The Role of the Pregnane X Receptor (PXR) in Indole Signaling and Intestinal Permeability in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Stool collection and Biopsy collection
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2015to 2 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- Control patients
Show all 20Show fewer
- 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
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
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
Read the 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 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
- Inflammatory Bowel Diseases
- Being tested
- Stool collection, Biopsy collection
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collectionDiagnostic 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 collectionDiagnostic test
3 additional biopsies (for research purposes) will be taken from patients who undergo colonoscopy as per standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Stool collection; Diagnostic Test: Biopsy collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Assays for biofilm and phage
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start25 Feb 2015
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sridhar Mani, Albert Einstein College of Medicine
- Investigators
- Sridhar Mani, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089501
- Sponsor's protocol ID
- 2015-4465
- Other IDs
- 3R01CA127231, 5R01CA161879
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Pregnane X Receptor (PXR) in Indole Signaling and Intestinal Permeability in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04089501
- Acronym / sponsor ID
- 2015-4465
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Feb 2015 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease (IBD) | – | Diagnostic Test: Stool collection, Diagnostic Test: Biopsy collectionSubjects 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. |
| Subjects not affected by IBD (Control Group) | – | Diagnostic Test: Stool collection, Diagnostic Test: Biopsy collectionResults of subjects with IBD will be compared to subjects in the control group. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool collectionStool 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. | Diagnostic test | Inflammatory Bowel Disease (IBD), Subjects not affected by IBD (Control Group) |
| Biopsy collection3 additional biopsies (for research purposes) will be taken from patients who undergo colonoscopy as per standard of care | Diagnostic test | Inflammatory Bowel Disease (IBD), Subjects not affected by IBD (Control Group) |
Primary outcome
Analysis of molecular studies in subjects with and without IBD
Time frame: Up to 5 years
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.
Assays for biofilm and phage
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sridhar Mani, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of molecular studies in subjects with and without IBD (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.