What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include anti-TNF agents (e.g., infliximab, adalimumab), thiopurines (e.g., azathioprine, 6-mercaptopurine), and mesalamine. Anti-TNF agents can cause infections, infusion reactions, and increased risk of certain cancers. Thiopurines are associated with bone marrow suppression, liver toxicity, and increased risk of infections and lymphomas. Mesalamine can cause headaches, nausea, and, rarely, kidney issues. These side effects must be weighed against the benefits of controlling IBD symptoms.

What prior FDA approvals exist?

FDA-approved treatments for Inflammatory Bowel Disease (IBD) include biologic agents such as infliximab and adalimumab, which are anti-TNF therapies used to manage Crohn's disease and ulcerative colitis. Other biologics like vedolizumab and ustekinumab have also shown efficacy in various clinical settings. Immunomodulators such as azathioprine and 6-mercaptopurine are used for their glucocorticoid-sparing effects. These treatments focus on reducing inflammation and promoting mucosal healing, which aligns with the objectives of studies analyzing gene expression and mitochondrial function in colonic ulcer healing.

What other types of research exist?

Promising novel alternatives to biopsy for IBD patients include advanced imaging techniques like confocal laser endomicroscopy, which allows for real-time, in vivo microscopic examination of the gastrointestinal mucosa. Additionally, non-invasive biomarkers such as fecal calprotectin and blood-based markers (e.g., C-reactive protein) are increasingly used to monitor inflammation and disease activity. Emerging technologies like multi-omics approaches (e.g., proteomics, metabolomics) and liquid biopsies (circulating cell-free DNA) also hold potential for providing comprehensive insights into gene expression and mitochondrial function without the need for traditional biopsies.

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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

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

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I have been diagnosed with rheumatoid or psoriatic arthritis.

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

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I do not have inflammatory bowel disease.

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I am currently on anti-TNF therapy.

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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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Inflammatory Bowel Disease (IBD) include aminosalicylates, glucocorticoids, immunomodulators, and biologics. Aminosalicylates, such as mesalamine, reduce inflammation in the gut lining by inhibiting the production of inflammatory mediators. Glucocorticoids, like prednisone, suppress the overall immune response to quickly reduce inflammation. Immunomodulators, such as azathioprine and 6-mercaptopurine, alter the immune system's activity to maintain remission and reduce dependency on steroids. Biologics, including anti-TNF agents like infliximab and adalimumab, target specific proteins involved in the inflammatory process. These treatments are crucial for IBD patients as they help manage symptoms, induce and maintain remission, and prevent complications. Understanding their mechanisms, especially in relation to gene expression and mitochondrial function, can lead to more personalized and effective treatment strategies.