Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04504136

Regulation of Mucosal Healing in Inflammatory Bowel Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Group 1):

  • Diagnosed ulcerative colitis or Crohn's disease
  • Biologic failure or naive to biologic treatment
  • Eligible to be treated with anti-TNF therapy

Inclusion criteria

(Group 2):

  • Diagnosed rheumatoid or psoriatic arthritis
  • Receiving anti-TNF antibody therapy at the time of enrollment

Inclusion criteria

(Group 3):

  • Endoscopically unremarkable colonic mucosa
  • Absence of inflammatory bowel disease

Exclusion criteria

  • 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
  • HIV positive
  • Incarceration
  • History of total proctocolectomy
  • History of system chemotherapy within 18 months
  • Uncontrolled intercurrent illness

Treatment and study plan

Serial Biopsy

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Fecal calprotectin levels

    Time frame: 35 days

    Levels of fecal calprotectin (ug/g) will be measured from stool samples collected from patients at any time during the study protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Neeraj Kapur, PhD

CONTACT

[email protected]

Terrence A Barrett, MD

CONTACT

[email protected]

8593234887

Sponsors and collaborators

Lead sponsor

Terrence A Barrett

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2020
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.