Inflammatory Bowel DiseasesNCT04504136
Regulation of Mucosal Healing in Inflammatory Bowel Disease
A study testing Serial Biopsy in people with Inflammatory Bowel Diseases, run by Terrence A Barrett at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Serial Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 15 Aug 2024
- Phase
- Interventional
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed ulcerative colitis or Crohn's disease
- Biologic failure or naive to biologic treatment
- Eligible to be treated with anti-TNF therapy
- Diagnosed rheumatoid or psoriatic arthritis
- Receiving anti-TNF antibody therapy at the time of enrollment
- Endoscopically unremarkable colonic mucosa
- Absence of inflammatory bowel disease
Who cannot join
- Classified in an anesthesia risk group, ASA Class =4
- History of bleeding diathesis or coagulopathy
- Stroke or transient neurological attack with the last 6 months
- Pregnant
- Receiving anticoagulants or anti-platelet medications other than low-dose aspirin
- Receiving steroid therapy or metformin
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- HIV positive
- Incarceration
- History of total proctocolectomy
- History of system chemotherapy within 18 months
- Uncontrolled intercurrent illness
Trial locations and contacts
1 site in 1 country.
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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Serial Biopsy
- Keywords
- mucosal, rheumatoid arthritis, psoriatic arthritis, ulcer, colitis, Crohn's, mitochondria, biopsy, wound, biologic, anti-TNF
- Medical subject headings
- Inflammatory Bowel Diseases, Arthritis, Rheumatoid, Arthritis, Psoriatic, Ulcer, Colitis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Participants in this group will be healthy (not diagnosed with inflammatory bowel disease). Receives: Procedure: Serial Biopsy |
| Inflammatory Bowel Disease | Experimental | 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. Receives: Procedure: Serial Biopsy |
| Rheumatoid/Psoriatic Arthritis | Experimental | 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. Receives: Procedure: Serial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Relative Ratio of Mitochondrial DNA to Nuclear DNA
Change in relative ratio of mitochondrial DNA to nuclear DNA in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Measured: 35 days
Fold Change in Expression Levels of cMyc
Fold change in expression levels of cMyc (mRNA) will be measured in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Measured: Baseline and 35 days
Fold Change in Expression Levels of PGC-1 Alpha
Fold change in 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.
Measured: Baseline and 35 days
Change in Expression Levels of Ki67
Change in Ki67 alpha (mRNA) expression will be measured by immunohistochemistry in epithelial cells collected from biopsies taken during the initial colonoscopy and at the follow-up colonoscopy.
Measured: 35 days
Number of Visible Ulcers
The number of visible ulcers will be assessed during the follow-up endoscopy for healthy patients and rheumatoid/psoriatic arthritis patients only.
Measured: 1 day (at follow-up visit)
Secondary outcomes (2)
Change in Full Mayo Score
Change in Full Mayo Score, a measure of inflammatory bowel disease activity, from baseline to 35 days. The Full Mayo Score ranges from 0-12, with higher scores indicating worse disease activity. The score is calculated by summing the four components of the Mayo Score: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment.
Measured: Baseline and 35 days
Change in Segmental SES-CD Score
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.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start30 Apr 2021
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terrence A Barrett
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terrence A Barrett, University of Kentucky
- Investigators
- Terrence Barrett, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504136
- Sponsor's protocol ID
- IMDDN-20-MUCOSALHEALING
- Other IDs
- 2R01DK095662-10A1
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2020
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No