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

Centre Hospitalier Universitaire de Saint Etienne80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Colitis, Ulcerative

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: day 1

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.