← Back to Search

Ulcer Healing Analysis for Inflammatory Bowel Disease

N/A

Recruiting

Led By Terrence Barrett, MD

Research Sponsored by Terrence A Barrett

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed ulcerative colitis or Crohn's disease

Diagnosed rheumatoid or psoriatic arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 days

Awards & highlights

Study Summary

This trial is comparing different types of ulcers to see if gene expression and mitochondrial function during ulcer healing can be used to improve treatments.

Who is the study for?

This trial is for people with ulcerative colitis or Crohn's disease who haven't responded to or haven't tried biologic treatments, and those with rheumatoid or psoriatic arthritis on anti-TNF therapy. Healthy individuals with normal colonic mucosa can also participate.Check my eligibility

What is being tested?

The study involves taking small tissue samples (biopsies) from the colon at two different times to compare healing processes in patients with IBD against those in healthy controls and arthritis patients.See study design

What are the potential side effects?

Since this trial involves serial biopsies, potential side effects include discomfort, bleeding, infection at the biopsy site, and rare complications related to endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ulcerative colitis or Crohn's disease.

Select...

I have been diagnosed with rheumatoid or psoriatic arthritis.

Select...

I have either not responded to biologic treatment or have never received it.

Select...

I do not have inflammatory bowel disease.

Select...

I am currently on anti-TNF therapy.

Select...

I am a candidate for anti-TNF therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in expression levels of Ki67

Change in expression levels of PGC-1 alpha

Change in expression levels of cMyc

+2 more

Secondary outcome measures

Change in Mayo Endoscopic Score

Change in Segmental SES-CD Score

Other outcome measures

Fecal calprotectin levels

Trial Design

3Treatment groups

Experimental Treatment

Group I: Rheumatoid/Psoriatic ArthritisExperimental Treatment1 Intervention

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 II: Inflammatory Bowel DiseaseExperimental Treatment1 Intervention

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 III: Healthy ControlsExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Terrence A BarrettLead Sponsor

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

2,369 Previous Clinical Trials

4,316,537 Total Patients Enrolled

Terrence Barrett, MDPrincipal InvestigatorUniversity of Kentucky

Media Library

Serial Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04504136 — N/A

Inflammatory Bowel Disease Research Study Groups: Inflammatory Bowel Disease, Rheumatoid/Psoriatic Arthritis, Healthy Controls

Inflammatory Bowel Disease Clinical Trial 2023: Serial Biopsy Highlights & Side Effects. Trial Name: NCT04504136 — N/A

Serial Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504136 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots still available in this clinical study?

"The trial listed on clinicaltrials.gov is actively seeking participants, having been first posted in April of 2021 and most recently edited a few days ago near the end of September 2022."

Answered by AI

What criteria make a person an ideal candidate for this experiment?

"In this clinical trial, 60 individuals with inflammatory bowel disease are needed who fall between 18 and 90 years of age. Critically, potential participants must have a history of biologic failure or lack thereof as well as an endoscopically unremarkable colonic mucosa."

Answered by AI

Is this investigation accepting volunteers aged 55 or above?

"This particular medical trial requires that participants are aged between 18 and 90. Additionally, there are 57 clinical trials available for minors while 149 studies cater to those 65 years old or older."

Answered by AI

What is the sample size of this research endeavor?

"Affirmative. Clinicaltrials.gov records demonstrate that this experiment is actively recruiting patients, with the initial posting taking place on April 30th 2021 and the latest update occurring September 26th 2022. This trial requires 60 participants from a single centre to take part."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Regulation of Mucosal Healing in Inflammatory Bowel Disease

Terrence A Barrett 2021. "Regulation of Mucosal Healing in Inflammatory Bowel Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04504136.

All > Inflammatory Bowel Disease > Colitis