Confocal Laser Endomicroscopy for IBD

Not yet recruiting at 1 trial location

Overseen By Sumith Roy, MBBS, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cook Children's Health Care System

Disqualifiers: Allergy to fluorescein, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Ongoing

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Confocal Laser Endomicroscopy, a special imaging technology, can predict treatment response in individuals with Inflammatory Bowel Disease (IBD). Researchers study gut tissue to determine if specific signals and cell patterns can forecast treatment success. The study aims to use artificial intelligence to categorize patients based on these patterns. Ideal participants include those with suspected or confirmed IBD, whether new to treatment or already receiving biologics, and patients with IBS (Irritable Bowel Syndrome) who have previously had negative endoscopy results for IBD. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It seems you can participate whether you are on treatment with biologics or not, but it's best to confirm with the trial coordinators.

What prior data suggests that Confocal Laser Endomicroscopy is safe for IBD patients?

Research has shown that Confocal Laser Endomicroscopy (CLE) is a promising tool for examining the intestines, particularly in individuals with Inflammatory Bowel Disease (IBD). Studies have found that CLE provides clear, real-time images of the gut's lining at a microscopic level, allowing doctors to detect inflammation and other changes more accurately than traditional methods.

Regarding safety, CLE is generally well-tolerated. As an imaging technique, it is less invasive than surgery. No significant reports of serious side effects have been directly linked to its use. However, like any procedure involving an endoscope (a flexible tube with a camera), minor discomfort may occur during the process.

Overall, CLE has been successfully used in both research and clinical settings for IBD patients. The absence of severe adverse events in previous studies suggests it is safe for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Confocal Laser Endomicroscopy (CLE) for IBD because it offers a new way to visualize and analyze the gastrointestinal tract at a microscopic level in real-time. Unlike traditional imaging and biopsy methods, which can be invasive and time-consuming, CLE allows doctors to see cellular changes directly during endoscopy procedures. This has the potential to improve the accuracy of IBD diagnosis and assessment, potentially leading to more personalized treatment plans and better patient outcomes.

What evidence suggests that Confocal Laser Endomicroscopy is effective for IBD?

Studies have shown that confocal laser endomicroscopy (CLE) can significantly aid in managing inflammatory bowel disease (IBD). Research suggests that CLE assesses colon inflammation more accurately than regular endoscopy. It provides live images of the gut lining at a cellular level, enabling doctors to observe changes and inflammation. In some cases, CLE has predicted patient response to treatments for conditions like Crohn's disease. This trial will use CLE to capture detailed images of the bowel, which promises to enhance doctors' understanding and management of IBD. ^{1 2 3 5 6}

Who Is on the Research Team?

Clifton Huang, MD

Principal Investigator

Cook Children's Health Care System

Are You a Good Fit for This Trial?

This trial is for children with Inflammatory Bowel Disease (IBD). It's designed to see if certain tests on biopsied tissue can predict how well they'll respond to treatment. Kids who have other conditions that might interfere with the study or pose a risk are not eligible.

Inclusion Criteria

Patients must fall into one of the below categories: (i) with suspected and/or established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls

Exclusion Criteria

Those with previous allergy to fluorescein

Pregnant and breastfeeding patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Assessment of fluorescent signal intensity at baseline using control antibody with control biopsy and IBD biopsy

1 week

1 visit (in-person)

Treatment

Participants undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with CLE as part of their clinical management

Ongoing

Multiple visits (in-person)

Follow-up

Participants are monitored for treatment response and mucosal healing using CLE

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Confocal Laser Endomicroscopy

Trial Overview Researchers are using Confocal Laser Endomicroscopy to examine IBD patients' biopsied tissues. They're looking at how cytokines bind and characterizing cells in inflamed tissue, aiming to create an AI algorithm that predicts treatment response.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Pediatric patients with clinical signs and symptoms suggestive of IBD or with established diagnosis of IBD (newly diagnosed or on therapeutic management) who are scheduled to undergo Esophagogastroduodenoscopy (EGD) and/or Ileocolonoscopy (IC) with CLE as part of their clinical management

Who Is Running the Clinical Trial?

Cook Children's Health Care System

Lead Sponsor

Trials

11

Recruited

5,001,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02481687

The Value of I-Scan and Confocal Laser Endomicroscopy ... CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment. Detailed Description. The value ...

2. nature.com nature.com/articles/s41598-025-21968-6

An automatic severity grading system using confocal laser ... Probe-based confocal laser endomicroscopy (pCLE) can accurately assess the UC inflammation than conventional endoscopy. The aim of this study ...

3. giejournal.org giejournal.org/article/S0016-5107(15)03068-0/fulltext

Confocal laser endomicroscopy in inflammatory bowel ... However, of these patients in clinical remission, less than one third (29%) were in concomitant endoscopic remission and the CD activity index demonstrated no ...

4. mdpi.com mdpi.com/2075-4418/13/7/1230

Impaired Intestinal Permeability Assessed by Confocal ... Prediction of clinical outcomes in Crohn's disease by using confocal laser endomicroscopy: Results from a prospective multicenter study.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26209861/

Confocal Laser Endomicroscopy in Inflammatory Bowel ... Confocal laser endomicroscopy is an endoscopic method that provides in vivo real-time imaging of the mucosa at a cellular level, elucidating mucosal changes.

6. gut.bmj.com gut.bmj.com/content/60/1/26

Confocal laser endomicroscopy is a new imaging modality ... Conclusions CLE is a new tool that can image intramucosal bacteria in vivo in patients with IBD. Intramucosal bacteria are found more frequently and with a ...