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

Not Applicable

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Procedure: confocal endomicroscopy

• Registration Number: NCT06624579
• Lead Sponsor: FEDERICA FURFARO

Brief Summary

This study employs a prospective, single-center, interventional design to investigate the prognostic value of confocal endomicroscopy in assessing treatment response in ulcerative colitis (UC) patients receiving small molecules .

Detailed Description

The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.

Eligible patients will undergo baseline assessment, including clinical evaluation, partial Mayo score calculation, endoscopic evaluation, biopsies with histological evaluation and confocal endomicroscopy. Follow-up assessments will be conducted at 8 weeks and 6 months after initiating therapy with small molecules .

The study aims to enroll a sample size of 26 UC patients to pilot the feasibility and utility of confocal endomicroscopy in assessing barrier dysfunction and treatment response.

Study Timeline

• Study First Submitted: 2024-08-21
• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-10
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
confocal endomicroscopy	confocal endomicroscopy	Endoscopic confocal microscopy with fluorescein injection is a medical imaging technique that combines endoscopy with confocal microscopy and the injection of fluorescein, a fluorescent dye. During colonoscopy or rettosigmoidoscopy, confocal microscopy is used, which provides high-resolution images of tissues at a cellular level. This technology uses a thin probe with a laser light source and a detection system to analyze specific layers of tissue. During the examination, a solution of fluorescein is injected into the patient's peripheric vein. Fluorescein is a dye that binds to cellular structures, making them fluorescent when exposed to laser light. This allows to visualize cellular details in real-time during endoscopy

Primary Outcome Measures

Name	Time	Method
Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis	at 8 weeks and 6 months to treatment initiation	The study incorporates confocal endomicroscopy as an additional diagnostic modality for assessing barrier dysfunction and treatment response in UC patients. Confocal endomicroscopy enables real-time visualization of mucosal changes at a cellular level during endoscopy, potentially enhancing the detection of treatment response and mucosal healing.