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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Colitis, Ulcerative

Treatments: Biological: blood sample; Procedure: rectosigmoidoscopy; Biological: biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT03172195

1708033

ANSM (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Patients with ulcerative colitis

Experimental group

Description:

Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.

Treatment:

Biological: biopsies

Procedure: rectosigmoidoscopy

Biological: blood sample