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

Colitis, Ulcerative Clinical Trial

— VIRCH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03172195
• Other study ID #: 1708033
• Secondary ID: ANSM
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

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.
• blood sample
Blood sample will be collected in more.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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