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

NCT03172195 | Terminated

• 2 other identifiers: 1708033ANSM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Colitis, Ulcerative

Keywords

ulcerative colitis; inflammation; immunosuppressive drugs; herpesvirus; qPCR; colonic mucosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation of the different viral loads with the Mayo endoscopic score

  Day 1

• Correlation of the different viral loads with the steroid treatment response

  up to 24 months

• Correlation of the different viral loads with the anti-TNF treatment response

  up to 24 months

Study Arms (1)

Patients with ulcerative colitis

EXPERIMENTAL

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

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

Interventions

rectosigmoidoscopy PROCEDURE

A rectosigmoidoscopy will be realized and two fragments will be collected.

Patients with ulcerative colitis

biopsies BIOLOGICAL

For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.

Patients with ulcerative colitis

blood sample BIOLOGICAL

Blood sample will be collected in more.

Patients with ulcerative colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammation; Herpes Simplex

Interventions

Biopsy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Punctures

Study Officials

• Xavier Roblin, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 1, 2017
• Study Start: October 11, 2017
• Primary Completion: March 13, 2024
• Study Completion: May 16, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)