Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis: the CONF-UC Study

Launched by FEDERICA FURFARO · Oct 1, 2024

Keywords

ClinConnect Summary

The CONF-UC Study is a clinical trial that aims to understand how a special imaging technique called confocal endomicroscopy can help doctors predict how well patients with ulcerative colitis (UC) will respond to new treatments. Ulcerative colitis is a condition that causes inflammation in the intestines, and this study will focus on patients who are starting treatment with small molecules, a type of medication for UC. The trial is not yet recruiting participants but is open to adults aged 18 and older who have been diagnosed with UC for at least 12 weeks and have active disease.

To be eligible for the study, participants must show signs of active ulcerative colitis, such as certain scores that indicate their symptoms, and they must not have any health issues that would prevent them from undergoing the tests involved in the study. Those who participate will undergo confocal endomicroscopy, which will allow doctors to take detailed images of the intestine during a procedure called endoscopy. This approach could help provide valuable information about the effectiveness of the treatment they are receiving. Overall, this study hopes to improve how doctors can tailor treatments for patients with ulcerative colitis based on their individual needs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Established diagnosis of UC since at least 12 weeks prior to inclusion
• • 2. Age ≥ 18 years
• • 3. Any gender/sex
• • 4. Active disease consistent with indication to start with Small molecules (defined as Mayo endoscopic score (MES) ≥ 1, partial Mayo score ≥ 3 (with at least rectal bleeding score of 1 and bowel movements score of 1)
• • 5. No contraindications to endoscopy or confocal exam
• • 6. Ability to understand and to comply with the study procedure and sign an informed consent form
• Exclusion Criteria:
• • 1. Subjects with an endoscopic Mayo sub-score at baseline \<2;
• • 2. Pregnancy
• • 3. Subjects with any contraindication to any study procedure (included fluorescein allergy).