Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up (VIRCH)

Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).

Study Overview

• Status: Terminated
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Procedure: rectosigmoidoscopy; Biological: biopsies; Biological: blood sample

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age>18 years
• Voluntary to participate to the study
• Flare-up of ulcerative colitis with Mayo score >6
• Ability to receive steroid or anti-TNF therapy
• Agree the rectosigmoidoscopy and the therapies

Exclusion Criteria:

• Age <18 years
• Pregnancy
• Disagree the rectosigmoidoscopy or the therapies
• Participation to the evaluation of a new therapy
• Colectomy (partial or total)
• Contraindication of steroid or anti-TNF therapy
• Anticoagulant drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with ulcerative colitis; Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.	Procedure: rectosigmoidoscopy; A rectosigmoidoscopy will be realized and two fragments will be collected.; Biological: biopsies; For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.; Biological: blood sample; Blood sample will be collected in more.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with different viral load in the colonic mucosa	Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the different viral loads with the Mayo endoscopic score	Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa The Mayo endoscopic score integrate the severity from lesions of colonic mucosa measured by rectosigmoidoscopy	Day 1
Correlation of the different viral loads with the steroid treatment response	Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa. Steroid treatment response is defined by clinic mayo score < 3 measured by rectosigmoidoscopy.	up to 24 months
Correlation of the different viral loads with the anti-TNF treatment response	Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa. anti-TNF treatment response is defined by clinic mayo score < 3 measured by rectosigmoidoscopy.	up to 24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Xavier Roblin, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: inflammation; ulcerative colitis; herpesvirus; immunosuppressive drugs; qPCR; colonic mucosa
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer
• Other Study ID Numbers: 1708033; ANSM (Other Identifier: 2025-A02220-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No