Colitis, Ulcerative
Conditions
Keywords
ulcerative colitis, inflammation, immunosuppressive drugs, herpesvirus, qPCR, colonic mucosa
Brief 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).
Interventions
PROCEDURErectosigmoidoscopy
A rectosigmoidoscopy will be realized and two fragments will be collected.
BIOLOGICALbiopsies
For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.
BIOLOGICALblood sample
Blood sample will be collected in more.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with different viral load in the colonic mucosa | day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the different viral loads with the Mayo endoscopic score | Day 1 | 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 |
| Correlation of the different viral loads with the steroid treatment response | up to 24 months | 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. |
| Correlation of the different viral loads with the anti-TNF treatment response | up to 24 months | 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. |
Countries
France
Outcome results
None listed