Inflammatory Bowel Diseases
Serial Colon Biopsies to Study Healing in Inflammatory Bowel Disease
This basic-science study uses biopsies from two colonoscopies to compare ulcer healing, gene expression, and mitochondrial function among adults with inflammatory bowel disease, adults with rheumatoid or psoriatic arthritis, and healthy controls.
Registry title: Regulation of Mucosal Healing in Inflammatory Bowel Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–90 Years
- Treatment
- Serial Biopsy
- Design
- Non Randomized
- Central study contact
- Terrence A Barrett, MD8593234887t.barrett@uky.edu
- Sponsor
- Terrence A Barrett
Research question
What differences in gene expression and mitochondrial function during colon-ulcer healing are seen between people with inflammatory bowel disease and the arthritis and healthy-control comparison groups?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 90.
- One group includes people with ulcerative colitis or Crohn's disease who have either not used biologic treatment or experienced biologic treatment failure and are eligible for anti-tumor necrosis factor therapy.
- Another group includes people with rheumatoid or psoriatic arthritis who are receiving anti-tumor necrosis factor antibody therapy when they enroll.
- A healthy-control group includes people without inflammatory bowel disease whose colon lining appears unremarkable during endoscopy.
- The registry lists one recruiting location at the University of Kentucky in Lexington, Kentucky.
Participation overview
What participation may involve
Participants undergo an initial colonoscopy with extra biopsies and marked biopsy sites, followed by a research colonoscopy that samples those areas again. Researchers analyze the samples for healing-related biological changes. What participation may involve: - Undergo an initial standard-of-care colonoscopy during which 16 to 20 research biopsies are collected in addition to standard-care biopsies. - Have the initial biopsy sites marked with tattoos so researchers can identify them later. - Return 4 to 35 days later for a research colonoscopy and 16 to 20 additional biopsies from the earlier biopsy areas. - Provide a stool sample at some point during the study for measurement of fecal calprotectin, a marker of intestinal inflammation. The registry states that the follow-up colonoscopy occurs 4 to 35 days after the initial colonoscopy; it does not state whether any other participation extends beyond that period. The described procedure schedule includes an initial colonoscopy and one follow-up colonoscopy 4 to 35 days later.
Study interventions
What participants may receive or do
- Serial Biopsy: During an initial colonoscopy, researchers collect 16 to 20 biopsies in addition to standard-care biopsies and tattoo the biopsy sites. Participants return 4 to 35 days later for another colonoscopy and 16 to 20 additional biopsies from the earlier biopsy areas.
Study design
How the comparison works
This is a non-randomized, open-label, basic-science study with three parallel groups. Every group undergoes the serial-biopsy procedure, and results are compared across inflammatory bowel disease, arthritis, and healthy-control groups. Participants are not assigned to groups at random; groups are defined by their diagnosis, treatment status, or healthy-control status. The registry reports no masking, meaning the study is open-label. Healthy participants and participants with rheumatoid or psoriatic arthritis serve as comparison groups for the inflammatory bowel disease group.
Reported activities
Procedures and tests
- An initial colonoscopy includes 16 to 20 research biopsies in addition to standard-care biopsies.
- Biopsy sites are marked with tattoos during the initial colonoscopy.
- A follow-up colonoscopy 4 to 35 days later includes another 16 to 20 biopsies from the earlier biopsy areas.
- Biopsy epithelial cells are tested for mitochondrial DNA copy number.
- Biopsy epithelial cells are tested for messenger RNA expression of cMyc, PGC-1 alpha, and Ki67.
- Visible ulcers are counted at follow-up for healthy participants and participants with rheumatoid or psoriatic arthritis.
- Participants with ulcerative colitis receive Mayo Endoscopic Score assessments at baseline and follow-up.
- Participants with Crohn's disease receive Simple Endoscopic Score for Crohn's Disease assessments at baseline and follow-up.
- A stool sample is tested for fecal calprotectin during the study.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- The inflammatory bowel disease group requires a diagnosis of ulcerative colitis or Crohn's disease.
- People in the inflammatory bowel disease group must either have experienced biologic treatment failure or never have received biologic treatment.
- People in the inflammatory bowel disease group must be eligible for anti-tumor necrosis factor therapy.
- The arthritis group requires a diagnosis of rheumatoid arthritis or psoriatic arthritis.
- People in the arthritis group must be receiving anti-tumor necrosis factor antibody therapy when they enroll.
- Healthy-control participants must have colon lining that appears unremarkable during endoscopy.
- Healthy-control participants must not have inflammatory bowel disease.
- Participants must be between 18 and 90 years old.
Possible reasons someone may not be able to join
- People classified as American Society of Anesthesiologists physical-status class 4 are excluded.
- A history of a bleeding disorder or impaired blood clotting excludes participation.
- A stroke or transient neurological attack within the previous six months excludes participation.
- Pregnant people are excluded.
- People taking anticoagulants or antiplatelet medicines are excluded, except those taking low-dose aspirin.
- People receiving steroid therapy or metformin are excluded.
- People who are HIV positive are excluded.
- A history of total surgical removal of the colon and rectum excludes participation.
- A history of systemic chemotherapy within the previous 18 months excludes participation.
- An uncontrolled illness occurring alongside the condition being studied excludes participation.
- People who are incarcerated are excluded.
Important unknowns
What the record does not make clear
- The record describes anti-tumor necrosis factor therapy requirements for the disease groups but does not fully explain which existing treatments may continue during the study.
- The registry does not state whether any allowed medicine must be stopped for a specific period before study procedures.
- The registry does not describe what treatment would be available if inflammatory bowel disease symptoms worsened during participation.
- The registry does not identify which clinical or research costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether travel, parking, lodging, or meal support is available.
- The study requires colonoscopies at baseline and follow-up, but the registry does not say whether any other activities can be completed remotely.
- The Lexington location is listed as recruiting, but the record does not state whether all three participant groups are currently open.
Before contacting the site
Questions for the study team
- Which of the three study groups are currently enrolling at the University of Kentucky?
- Which of my current medicines could continue, and would any medicine need to be paused before either colonoscopy?
- What preparation, sedation, recovery time, and procedure-related risks apply to each colonoscopy and the additional biopsies?
- What care is available if inflammatory bowel disease symptoms worsen between the initial and follow-up colonoscopies?
- Which study-related costs are covered, what may be billed to insurance, and is compensation or travel support available?
- When must the stool sample be collected, and can it be collected or returned from home?
Before changing care
Questions for your gastroenterologist
- Would the study's anti-tumor necrosis factor therapy requirements or medication exclusions conflict with my current treatment plan?
- Is my disease stable enough for two colonoscopies and the additional biopsies described in this study?
- What approved treatment alternatives should I consider alongside learning about this research study?
- How should you and the research team coordinate medication decisions, colonoscopy timing, biopsy results, and care if my symptoms change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing.
Induction of mucosal healing in inflammatory bowel disease (IBD) is associated with reduced hospitalizations, surgeries, and reduced cancer risk. However, previous studies have shown that 54-69% of ulcerative colitis (UC) patients fail to heal ulcers after several weeks of treatment, and roughly half do not maintain remission at one year. The single most important factor in preventing severe medical consequences, like colon removal surgery or cancer, is treatment to completely heal the top layer of the intestine as quickly as possible. Healing is a complex process and the dysfunction observed in colitis can only be fully understood by comparison to healing in non-IBD patients. This is a prospective trial involving three groups of patients: 1) IBD patients with active disease, newly treated with anti-TNF therapy (biologic failure or naïve); 2) non-IBD patients with rheumatoid/psoriatic arthritis who are receiving anti-TNF therapy, and 3) healthy control patients. Biopsies will be collected at baseline during standard of care endoscopy and at a follow-up research endoscopy. This study will probe mechanisms of ulcer healing by analyzing gene expression patterns and mitochondrial function.
Study design and administration
- Organization
- University of Kentucky
- Organization class
- Other
- Organization study ID
- IMDDN-20-MUCOSALHEALING
- Lead sponsor
- Terrence A Barrett
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Basic Science
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Healthy Controls
Participants in this group will be healthy (not diagnosed with inflammatory bowel disease).
Interventions: Procedure: Serial Biopsy
Experimental
Inflammatory Bowel Disease
Participants in this group will have been diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) and have either failed treatment with biologics or be naive to biologic therapy.
Interventions: Procedure: Serial Biopsy
Experimental
Rheumatoid/Psoriatic Arthritis
Participants in this group will have been diagnosed with rheumatoid (RA) or psoriatic arthritis (PsA) and will be receiving anti-TNF antibody therapy at the time of enrollment.
Interventions: Procedure: Serial Biopsy
Interventions
Procedure
Serial Biopsy
During the initial colonoscopy, 16-20 biopsies will be collected in addition to standard of care biopsies, and biopsy sites will be tattoed. Patients will return for a follow-up colonoscopy 4-35 days later. An additional 16-20 biopsies will be collected in a "biopsy of the biopsy" approach.
Eligibility
18 Years–90 Years
All
Accepted
Inclusion criteria (7)
- Diagnosed ulcerative colitis or Crohn's diseaseRegistry-derived · unreviewed
- Biologic failure or naive to biologic treatmentRegistry-derived · unreviewed
- Eligible to be treated with anti-TNF therapyRegistry-derived · unreviewed
- Diagnosed rheumatoid or psoriatic arthritisRegistry-derived · unreviewed
- Receiving anti-TNF antibody therapy at the time of enrollmentRegistry-derived · unreviewed
- Endoscopically unremarkable colonic mucosaRegistry-derived · unreviewed
- Absence of inflammatory bowel diseaseRegistry-derived · unreviewed
Exclusion criteria (11)
- Classified in an anesthesia risk group, ASA Class =4Registry-derived · unreviewed
- History of bleeding diathesis or coagulopathyRegistry-derived · unreviewed
- Stroke or transient neurological attack with the last 6 monthsRegistry-derived · unreviewed
- PregnantRegistry-derived · unreviewed
- Receiving anticoagulants or anti-platelet medications other than low-dose aspirinRegistry-derived · unreviewed
- Receiving steroid therapy or metforminRegistry-derived · unreviewed
- HIV positiveRegistry-derived · unreviewed
- IncarcerationRegistry-derived · unreviewed
- History of total proctocolectomyRegistry-derived · unreviewed
- History of system chemotherapy within 18 monthsRegistry-derived · unreviewed
- Uncontrolled intercurrent illnessRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in mitochondrial DNA copy number
Time frame: 35 days
Mitochondrial DNA copy number will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Primary outcome
Change in expression levels of cMyc
Time frame: 35 days
Relative expression of cMyc (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Primary outcome
Change in expression levels of PGC-1 alpha
Time frame: 35 days
Relative expression of PGC-1 alpha (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Primary outcome
Change in expression levels of Ki67
Time frame: 35 days
Relative expression of Ki67 alpha (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Primary outcome
Number of visible ulcers
Time frame: 1 day (at follow-up visit)
The number of visible ulcers will be assessed during the follow-up endoscopy for healthy patients and rheumatoid/psoriatic arthritis patients only.
Secondary outcome
Change in Mayo Endoscopic Score
Time frame: 35 days
The Mayo Endoscopic Score will be calculated at baseline and at follow-up in patients with ulcerative colitis only. The Mayo Endoscopic score is evaluated for the macroscopically most severely inflamed segment: 0 for normal or inactive disease; 1 for erythema, decreased vascular pattern, mild friability; 2 for marked erythema, absent vascular pattern, friability, erosions; 3 ulcerations or spontaneous bleeding. Segmental scores range from 0-3; higher scores indicate more severe disease.
Secondary outcome
Change in Segmental SES-CD Score
Time frame: 35 days
The Simple Endoscopic Score (SES) will be calculated at baseline and follow-up in patients with Crohn's disease (CD) only. The SES-CD score incorporates ulcer size, narrowing, and the area affected by disease or ulceration. Scores range from 0-12; lower scores indicate remission while higher scores indicate severe endoscopic activity.
Recruiting locations in the United States
University of Kentucky
RecruitingLexington, Kentucky, 40536, United States
Syed Adeel Hassan, MBBS/MD312-340-4925syed.hassan@uky.edu
Central study contacts
Registry dates
- First posted
- Aug 7, 2020
- Primary completion
- Jun 1, 2026
- Overall completion
- Jun 1, 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.