NCT03172195

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-11
• Primary completion: 2024-03-13
• Completion: 2024-05-16
• First posted: 2017-06-01
• Last updated: 2025-06-05

Locations

1 site across 1 country: France