Regulation of Mucosal Healing in Inflammatory Bowel Disease

NCT ID: NCT04504136

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2026-06-01

Brief 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. 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Controls

Participants in this group will be healthy (not diagnosed with inflammatory bowel disease).

Group Type: EXPERIMENTAL

Serial Biopsy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Serial Biopsy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Serial Biopsy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Terrence A Barrett

OTHER

Sponsor Role: lead

Responsible Party

Terrence A Barrett

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Terrence Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Terrence A Barrett, MD

Role: CONTACT

t.barrett@uky.edu

8593234887

Neeraj Kapur, PhD

Role: CONTACT

neeraj.kapur@uky.edu

Facility Contacts

Syed Adeel Hassan, MBBS/MD

Role: primary

syed.hassan@uky.edu

312-340-4925

Other Identifiers

2R01DK095662-10A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IMDDN-20-MUCOSALHEALING

Identifier Type: -

Identifier Source: org_study_id