Regulation of Mucosal Healing in Inflammatory Bowel Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04504136
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Terrence A Barrett
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Terrence Barrett, MD
Principal Investigator Affiliation University of Kentucky
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Diseases
Additional Details

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.

Arms & Interventions

Arms

Experimental: Healthy Controls

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

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.

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kentucky, Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky

Lexington, Kentucky, 40536

Site Contact

Syed Adeel Hassan, MBBS/MD

syed.hassan@uky.edu

312-340-4925

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