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

Study Overview
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Brief Summary
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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).

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

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Procedure: rectosigmoidoscopy
* Biological: biopsies
* Biological: blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, inflammation, immunosuppressive drugs, herpesvirus, qPCR, colonic mucosa