Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| confocal endomicroscopy | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| confocal endomicroscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic Value of Confocal Endomicroscopy in Ulcerative Colitis | 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. | at 8 weeks and 6 months to treatment initiation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FEDERICA FURFARO GASTROENTEROLOGIST | Contact | 0039+0226432069 | furfaro.federica@hsr.it |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
26 adult subjects with moderate-to-severe active (defined as having patient-reported outcomes, PRO > 2), left-sided or extensive UC, requiring small molecules therapy according to the standards of care (ECCO guidelines) and performing routine investigations with Colonoscopy before starting appropriate therapy, according to the current standard of care indications and ECCO guidelines.
Not provided
Not provided
Not provided
Not provided
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |