Colitis, UlcerativeVIRCHNCT03172195
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
A study testing rectosigmoidoscopy, biopsies and blood sample in people with Colitis, Ulcerative, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- rectosigmoidoscopy, biopsies and blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2017to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- rectosigmoidoscopy, biopsies, blood sample
- Keywords
- ulcerative colitis, inflammation, immunosuppressive drugs, herpesvirus, qPCR, colonic mucosa
- Medical subject headings
- Colitis, Ulcerative, Inflammation, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectosigmoidoscopyProcedure or surgery
A rectosigmoidoscopy will be realized and two fragments will be collected.
biopsiesBiological
For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.
blood sampleBiological
Blood sample will be collected in more.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ulcerative colitis | Experimental | Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample. Receives: Procedure: rectosigmoidoscopy; Biological: biopsies; Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (3)
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
Measured: Day 1
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.
Measured: up to 24 months
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start11 Oct 2017
- Primary completion13 Mar 2024
- Study completion16 May 2024
Why it stopped: * Lack of inclusion * Inability to open investigator centers due to lack of budget
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Roblin, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172195
- Sponsor's protocol ID
- 1708033
- Other IDs
- ANSM
- Acronym
- VIRCH
- Status last verified
- Jun 2025
- First submitted
- 23 May 2017
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
- ClinicalTrials.gov ID
- NCT03172195
- Acronym / sponsor ID
- VIRCH / 1708033
- Conditions
- Colitis, Ulcerative
- Keywords
- ulcerative colitis, inflammation, immunosuppressive drugs, herpesvirus, qPCR, colonic mucosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: * Lack of inclusion * Inability to open investigator centers due to lack of budget
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ulcerative colitis | Experimental | Procedure: rectosigmoidoscopy, Biological: biopsies, Biological: blood samplePatients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnancy
- Disagree the rectosigmoidoscopy or the therapies
- Participation to the evaluation of a new therapy
- Colectomy (partial or total)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectosigmoidoscopyA rectosigmoidoscopy will be realized and two fragments will be collected. | Procedure or surgery | Patients with ulcerative colitis |
| biopsiesFor this study, two biopsies in healthy area and two biopsies in ulcer will be collected. | Biological | Patients with ulcerative colitis |
| blood sampleBlood sample will be collected in more. | Biological | Patients with ulcerative colitis |
Primary outcome
Number of patients with different viral load in the colonic mucosa
Time frame: 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
3 secondary outcomes
Correlation of the different viral loads with the Mayo endoscopic score
Time frame: Day 1
Correlation of the different viral loads with the steroid treatment response
Time frame: up to 24 months
Correlation of the different viral loads with the anti-TNF treatment response
Time frame: up to 24 months
Results and safety
The study was stopped early (reason given: * Lack of inclusion * Inability to open investigator centers due to lack of budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Roblin, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rectosigmoidoscopy, biopsies and blood sample in people with Colitis, Ulcerative, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: * Lack of inclusion * Inability to open investigator centers due to lack of budget). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with different viral load in the colonic mucosa (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.