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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03172195
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xavier Roblin, MD PhD
Principal Investigator Affiliation CHU SAINT-ETIENNE
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Arms & Interventions

Arms

Experimental: Patients with ulcerative colitis

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Saint-Etienne, Saint-Etienne, France

Status

Recruiting

Address

CHU Saint-Etienne

Saint-Etienne, , 42055

Site Contact

Xavier ROBLIN, MD PhD

xavier.roblin@chu-st-etienne.fr

(0)477828119 #+33