Inflammatory Bowel DiseaseNCT01171872
Gene Expression in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who are to undergo upper or lower gastrointestinal endoscopies or a surgical resection as part of their normal medical care and deemed necessary by their physicians. Patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals can contact us by phone, mail or email after hearing about our study.
Who may be able to join
- All persons, regardless of IBD affection status, greater than 7 years of age undergoing upper or lower endoscopy or bowel resection
Who cannot join
- Persons with bleeding tendencies
- Persons on anti-coagulation therapy or who will be place on anti-coagulation therapy following the planned endoscopy procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
About this study
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This protocol is aimed at obtaining tissue samples to test for expression of genes associated with IBD and to better understand the pathogenesis of IBD with the study of genetics, proteomics, physiologic processes and microbiomes (microbiology).
Read the detailed description
Progress has been made in recent years in understanding the pathological mechanisms of IBD, particularly in the search of IBD susceptibility genes. However, due to the extreme complexity of the diseases, there is still a long way ahead in elucidating detailed molecular mechanisms of IBD pathogenesis and identifying more effective therapeutic targets. Therefore, it is the goal of this research study to discover genetic, microbial, gene expression and serological factors involved in the pathogenesis of IBD which may pave the way for the identification of more effective therapeutic targets.
The specific aims for these objectives are as follows:
AIM 1: Identify proteins that are changed in expression and post-translational modification in the intestinal mucosa of patients with active UC or CD compared to i) uninvolved intestinal mucosa from the same patients, ii) normal intestinal mucosa in control subjects, and iii) infectious/Inflammatory colitis (C. difficile colitis).
AIM 2: Identify changes in the expression of intestinal membrane transporters for Na absorption and Cl secretion, including NHE3, in the intestinal mucosa of patients with active UC or CD compared to i) uninvolved intestinal mucosa from the same patients, ii) normal intestinal mucosa in control subjects, and and iii) infectious/Inflammatory colitis (C. difficile colitis). The targeted screening will also include several intestinal epithelial brush border-associated PDZ-containing proteins that have been recently shown to regulate trafficking and activity of membrane transporters.
AIM 3: Enteroid Sub-study - To compare the physiologic regulation of Na absorption, Cl secretion, protein secretion and other intestinal physiologic processes in IBD cases, other infectious colitis cases and healthy controls as these processes are often altered with disease activities. The processes will be studied through the development of self-propagating culture models called organoids or enteroids. The culture models are developed from biopsy specimens taken from the upper small intestine, including duodenum and jejunum , lower small intestine (ileum) and proximal and distal colon and used to grow organoids/enteroids. These are mini-intestines that have the entire crypt villus axes which grow in culture and can be kept alive indefinitely in culture.
AIM 4: Mechanism of Intestinal Inflammation Sub-study - To understand the mechanisms involved in the recurrence of inflammation following ileal resection surgery for Crohn's disease (CD). Reasons for recurrence are currently unknown but are believed to be caused by an interaction of genetic, immune and microbial features. Information gained from this study will be used to build a predictive model to identify those patients at greater risk of rapid recurrence, and will aid physicians in tailoring follow-up treatments.
AIM 5: UC Demarcation Sub-study - To gain further understanding of the mechanisms involved in the susceptibility to and flare of inflammation in UC patients. Blood, stool, urine, saliva, lavage and tissue samples from UC patients will be used to help study the genetic, microbial, metabolic, and immune factors involved in the remission and flare of disease. Information gained from this study will also be used to build a predictive model of which patients are at greater risk of disease flare, and which are less likely to do so, allowing physicians to tailor follow-up treatments accordingly.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, IBD, CD, UC, IC
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unaffected | Individuals who do not have IBD | |
| Affected | Individuals who have IBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression in IBD
Measured: Single visit, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startNov 1999
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Florin Selaru, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171872
- Sponsor's protocol ID
- NA_00038329
- Other IDs
- U01DK062431, R24DK099803, P01AI125181
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2010
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01171872
- Acronym / sponsor ID
- NA_00038329
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, IBD, CD, UC
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 1999 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 29 Jul 2010 (estimated)
- 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.
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a idiopathic, chronic and frequently disabling inflammatory disorder of the intestines characterized by a dysregulated mucosal immune response that affect more than a million Americans. This protocol is aimed at obtaining tissue samples to test for expression of genes associated with IBD and to better understand the pathogenesis of IBD with the study of genetics, proteomics, physiologic processes and microbiomes (microbiology).
Detailed description
Progress has been made in recent years in understanding the pathological mechanisms of IBD, particularly in the search of IBD susceptibility genes. However, due to the extreme complexity of the diseases, there is still a long way ahead in elucidating detailed molecular mechanisms of IBD pathogenesis and identifying more effective therapeutic targets. Therefore, it is the goal of this research study to discover genetic, microbial, gene expression and serological factors involved in the pathogenesis of IBD which may pave the way for the identification of more effective therapeutic targets.
The specific aims for these objectives are as follows:
AIM 1: Identify proteins that are changed in expression and post-translational modification in the intestinal mucosa of patients with active UC or CD compared to i) uninvolved intestinal mucosa from the same patients, ii) normal intestinal mucosa in control subjects, and iii) infectious/Inflammatory colitis (C. difficile colitis).
AIM 2: Identify changes in the expression of intestinal membrane transporters for Na absorption and Cl secretion, including NHE3, in the intestinal mucosa of patients with active UC or CD compared to i) uninvolved intestinal mucosa from the same patients, ii) normal intestinal mucosa in control subjects, and and iii) infectious/Inflammatory colitis (C. difficile colitis). The targeted screening will also include several intestinal epithelial brush border-associated PDZ-containing proteins that have been recently shown to regulate trafficking and activity of membrane transporters.
AIM 3: Enteroid Sub-study - To compare the physiologic regulation of Na absorption, Cl secretion, protein secretion and other intestinal physiologic processes in IBD cases, other infectious colitis cases and healthy controls as these processes are often altered with disease activities. The processes will be studied through the development of self-propagating culture models called organoids or enteroids. The culture models are developed from biopsy specimens taken from the upper small intestine, including duodenum and jejunum , lower small intestine (ileum) and proximal and distal colon and used to grow organoids/enteroids. These are mini-intestines that have the entire crypt villus axes which grow in culture and can be kept alive indefinitely in culture.
AIM 4: Mechanism of Intestinal Inflammation Sub-study - To understand the mechanisms involved in the recurrence of inflammation following ileal resection surgery for Crohn's disease (CD). Reasons for recurrence are currently unknown but are believed to be caused by an interaction of genetic, immune and microbial features. Information gained from this study will be used to build a predictive model to identify those patients at greater risk of rapid recurrence, and will aid physicians in tailoring follow-up treatments.
AIM 5: UC Demarcation Sub-study - To gain further understanding of the mechanisms involved in the susceptibility to and flare of inflammation in UC patients. Blood, stool, urine, saliva, lavage and tissue samples from UC patients will be used to help study the genetic, microbial, metabolic, and immune factors involved in the remission and flare of disease. Information gained from this study will also be used to build a predictive model of which patients are at greater risk of disease flare, and which are less likely to do so, allowing physicians to tailor follow-up treatments accordingly.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unaffected | – | –Individuals who do not have IBD |
| Affected | – | –Individuals who have IBD |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who are to undergo upper or lower gastrointestinal endoscopies or a surgical resection as part of their normal medical care and deemed necessary by their physicians. Patients are primarily recruited at the Johns Hopkins inpatient and outpatient units. However, individuals can contact us by phone, mail or email after hearing about our study.
Key inclusion criteria (1 listed)
- All persons, regardless of IBD affection status, greater than 7 years of age undergoing upper or lower endoscopy or bowel resection
Key exclusion criteria (2 listed)
- Persons with bleeding tendencies
- Persons on anti-coagulation therapy or who will be place on anti-coagulation therapy following the planned endoscopy procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene Expression in IBD
Time frame: Single visit, approximately 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Inflammatory Bowel Disease
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingPhase 4
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
Crohn Disease
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
RecruitingObservational study
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel Disease, Ulcerative Colitis
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.
Florin Selaru, M.D. principal investigator
Johns Hopkins University
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 Disease, run by Johns Hopkins University 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gene Expression in IBD (time frame: Single visit, approximately 1 hour). 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 Jan 2026.