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

NCT ID: NCT03172195

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2024-05-16

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).

Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with ulcerative colitis

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

Group Type EXPERIMENTAL

rectosigmoidoscopy

Intervention Type PROCEDURE

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

biopsies

Intervention Type BIOLOGICAL

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

blood sample

Intervention Type BIOLOGICAL

Blood sample will be collected in more.

Interventions

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rectosigmoidoscopy

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

Intervention Type PROCEDURE

biopsies

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

Intervention Type BIOLOGICAL

blood sample

Blood sample will be collected in more.

Intervention Type BIOLOGICAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Roblin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1708033

Identifier Type: -

Identifier Source: org_study_id

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