Moderate to Severe Ulcerative ColitisMIROIRNCT07653750
Study on Variation of Serum and Fecal Biomarkers After Treatment to Predict Mucosal Healing in Patients With Ulcerative Colitis
A study testing Serum and fecal measurements in people with Moderate to Severe Ulcerative Colitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Mucosal healing is recognized hitherto as the best therapeutic endpoint in patients with Ulcerative Colitis (UC) but its use in daily practice is limited by the low acceptability of repeated colonoscopies. In this context, fecal biomarkers are attractive alternatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Ulcerative Colitis
- What is being tested?
- Serum and fecal measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2021to 9 Jun 2026
- 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
- Patients with Ulcerative Colitis
- Age ≥ 18 years
- Presence of endoscopic activity (Mayo endoscopic score ≥ 2) requiring the introduction, increase or change of treatment
- Patients able to consent
- Non Inclusion Criteria :
- Patients not affiliated to the social security system
Show all 10Show fewer
- Pregnant or breastfeeding woman
- Patients who have total coloproctectomy with ileo-anal anastomosis
- Acute Severe Ulcerative Colitis (ASUC)
- Persons under guardianship, trusteeship or imprisonment
Who cannot join
- Patient wishing to discontinue participation in the study for any reason
- Study exit at the investigator's discretion
- Pregnancy Discovery
Trial locations and contacts
1 site in 1 country.
About this study
Mucosal healing is recognized hitherto as the best therapeutic endpoint in patients with Ulcerative Colitis (UC) but its use in daily practice is limited by the low acceptability of repeated colonoscopies. In this context, fecal biomarkers are attractive alternatives. Fecal calprotectin showed very good negative predictive value to eliminate IBD diagnosis, good correlation to endoscopic activity and good ability to predict relapse. Recently, several teams including ours, showed that fecal biomarkers such as Chitinase 3-Like 1 (CHI3L1), matrix metalloprotease type 9 (MMP-9) and serum biomarkers neutrophil gelatinase B- complex associated lipocalin (NGAL)-MMP9 and serum CHI3L1 could be better biomarkers than fecal calprotectin to assess endoscopic activity in patients with UC.
Read the detailed description
Patients with UC requiring endoscopy (colonoscopy or recto sigmoidoscopy) in their management and with endoscopic activity (Mayo endoscopic score ≥ 2) will be offered inclusion in this study.
Blood and faecal samples will be taken in addition to the usual care measurements for the determination of biomarkers under study. Routine care biopsies will be performed in each patient during endoscopy to assess histologic activity.
Because of endoscopic activity, treatment will be changed (start, increase or change treatment) according to current recommendations. After several weeks of treatment (8 ± 4 weeks for 5-ASA and corticosteroids, 12 to 24 weeks for immunosuppressants and 12 ± 2 weeks for biotherapies), patients will have an evaluation performed by endoscopy (colonoscopy or rectosigmoidoscopy) with biopsies for histological analysis (routine care). Blood and faecal samples will be taken in addition to the usual care measurements (blood count, albumin, CRP and faecal calprotectin...) for the determination of biomarkers under study.
Every patient will have a follow-up every 3 months for 1 year with clinical evaluation, blood and faecal biomarker assays and each patient will have a new endoscopic evaluation with biopsies for histological analysis at 12 months.
- Conditions
- Moderate to Severe Ulcerative Colitis
- Being tested
- Serum and fecal measurements
- Keywords
- Ulcerative colitis, Mucosal healing, Histological healing, Chitinase 3-Like-1 (CHI3L1), Matrix metalloprotease type (MMP-9), Serum biomarkers, Fecal biomarkers, NGAL-MMP9 complex
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and fecal measurementsBiological
- Serum measurements: NGAL-MMP9 and CHI3L1
- Fecal measurements: Calprotectin, CHI3L1 and MMP9
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by an ulcerative colitis | Experimental | Predict mucosal healing in patients with ulcerative colitis by measures on the variation of serum and fecal biomarkers after treatment. Receives: Biological: Serum and fecal measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum measurements: CHI3L1 and NGAL-MMP9
Measurements in Blood samples
Measured: Serum change from baseline to month 3
Serum measurements: CHI3L1 and NGAL-MMP9
Measurements in Blood samples
Measured: Serum change from baseline to month 6
Serum measurements: CHI3L1 and NGAL-MMP9
Measurements in Blood samples
Measured: Serum change from baseline to month 9
Serum measurements: CHI3L1 and NGAL-MMP9
Measurements in Blood samples
Measured: Serum change from baseline to month 12
Fecal measurements: CHI3L1, MMP9
Measurements in Stool samples
Measured: Comparison between baseline and month 3
Fecal measurements: CHI3L1, MMP9
Measurements in Stool samples
Measured: Comparison between baseline and month 6
Fecal measurements: CHI3L1, MMP9
Measurements in Stool samples
Measured: Comparison between baseline and month 9
Fecal measurements: CHI3L1, MMP9
Measurements in Stool samples
Measured: Comparison between baseline and month 12
Secondary outcomes (6)
Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
Mucosal healing defined as Mayo Endoscopic Score ≤1 (Mayo 0 : normal mucosa or inactive disease ; Mayo 1 : mild activity (erythema, decreased vascular pattern, mild friability); Mayo 2 : moderate activity (marked erythema, lack of vascular patterne, friability, erosions); Mayo 3 : severe activity (spontaneus bleeding, large ulcerations)).
Measured: Comparison between baseline and month 3
Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
Mucosal healing defined as Mayo Endoscopic Score ≤1 (Mayo 0 : normal mucosa or inactive disease ; Mayo 1 : mild activity (erythema, decreased vascular pattern, mild friability); Mayo 2 : moderate activity (marked erythema, lack of vascular patterne, friability, erosions); Mayo 3 : severe activity (spontaneus bleeding, large ulcerations)).
Measured: Comparison between baseline and month 12
Histological Healing Assessed by Geboes Score
Measured: Comparison between baseline and month 3
Histological Healing Assessed by Nancy Histological Index
Measured: Comparison between baseline and month 3
Histological Healing Assessed by Geboes Score
Measured: Comparison between baseline and month 12
Histological Healing Assessed by Nancy Histological Index
Measured: Comparison between baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start25 Jun 2021
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Why it stopped: We were able to test our hypothesis using the current data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants (patients with an ulcerative colitis) receive the same intervention : serum measurements (NGAL-MMP9, CHI3L1) and fecal measurements (Calprotectin, CHI3L1, MMP9).
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony BUISSON, MD, PhD, Principal investigator, - CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653750
- Sponsor's protocol ID
- CHU-398
- Other IDs
- 2017-A02918-45
- Acronym
- MIROIR
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2018
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Variation of Serum and Fecal Biomarkers After Treatment to Predict Mucosal Healing in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07653750
- Acronym / sponsor ID
- MIROIR / CHU-398
- Conditions
- Moderate to Severe Ulcerative Colitis
- Keywords
- Ulcerative colitis, Mucosal healing, Histological healing, Chitinase 3-Like-1 (CHI3L1), Matrix metalloprotease type (MMP-9), Serum biomarkers, Fecal biomarkers, NGAL-MMP9 complex
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were able to test our hypothesis using the current data
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 17 Jun 2026 (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.
Mucosal healing is recognized hitherto as the best therapeutic endpoint in patients with Ulcerative Colitis (UC) but its use in daily practice is limited by the low acceptability of repeated colonoscopies. In this context, fecal biomarkers are attractive alternatives. Fecal calprotectin showed very good negative predictive value to eliminate IBD diagnosis, good correlation to endoscopic activity and good ability to predict relapse. Recently, several teams including ours, showed that fecal biomarkers such as Chitinase 3-Like 1 (CHI3L1), matrix metalloprotease type 9 (MMP-9) and serum biomarkers neutrophil gelatinase B- complex associated lipocalin (NGAL)-MMP9 and serum CHI3L1 could be better biomarkers than fecal calprotectin to assess endoscopic activity in patients with UC.
Detailed description
Patients with UC requiring endoscopy (colonoscopy or recto sigmoidoscopy) in their management and with endoscopic activity (Mayo endoscopic score ≥ 2) will be offered inclusion in this study.
Blood and faecal samples will be taken in addition to the usual care measurements for the determination of biomarkers under study. Routine care biopsies will be performed in each patient during endoscopy to assess histologic activity.
Because of endoscopic activity, treatment will be changed (start, increase or change treatment) according to current recommendations. After several weeks of treatment (8 ± 4 weeks for 5-ASA and corticosteroids, 12 to 24 weeks for immunosuppressants and 12 ± 2 weeks for biotherapies), patients will have an evaluation performed by endoscopy (colonoscopy or rectosigmoidoscopy) with biopsies for histological analysis (routine care). Blood and faecal samples will be taken in addition to the usual care measurements (blood count, albumin, CRP and faecal calprotectin...) for the determination of biomarkers under study.
Every patient will have a follow-up every 3 months for 1 year with clinical evaluation, blood and faecal biomarker assays and each patient will have a new endoscopic evaluation with biopsies for histological analysis at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants (patients with an ulcerative colitis) receive the same intervention : serum measurements (NGAL-MMP9, CHI3L1) and fecal measurements (Calprotectin, CHI3L1, MMP9).
| Arm | Type | Receives |
|---|---|---|
| Patients affected by an ulcerative colitis | Experimental | Biological: Serum and fecal measurementsPredict mucosal healing in patients with ulcerative colitis by measures on the variation of serum and fecal biomarkers after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with Ulcerative Colitis
- Age ≥ 18 years
- Presence of endoscopic activity (Mayo endoscopic score ≥ 2) requiring the introduction, increase or change of treatment
- Patients able to consent
- Patients not affiliated to the social security system
Key exclusion criteria (3 listed)
- Patient wishing to discontinue participation in the study for any reason
- Study exit at the investigator's discretion
- Pregnancy Discovery
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 |
|---|---|---|
| Serum and fecal measurements* Serum measurements: NGAL-MMP9 and CHI3L1 * Fecal measurements: Calprotectin, CHI3L1 and MMP9 | Biological | Patients affected by an ulcerative colitis |
Primary outcome
Serum measurements: CHI3L1 and NGAL-MMP9
Time frame: Serum change from baseline to month 3
Measurements in Blood samples
Serum measurements: CHI3L1 and NGAL-MMP9
Time frame: Serum change from baseline to month 6
Measurements in Blood samples
Serum measurements: CHI3L1 and NGAL-MMP9
Time frame: Serum change from baseline to month 9
Measurements in Blood samples
Serum measurements: CHI3L1 and NGAL-MMP9
Time frame: Serum change from baseline to month 12
Measurements in Blood samples
Fecal measurements: CHI3L1, MMP9
Time frame: Comparison between baseline and month 3
Measurements in Stool samples
Fecal measurements: CHI3L1, MMP9
Time frame: Comparison between baseline and month 6
Measurements in Stool samples
Fecal measurements: CHI3L1, MMP9
Time frame: Comparison between baseline and month 9
Measurements in Stool samples
Fecal measurements: CHI3L1, MMP9
Time frame: Comparison between baseline and month 12
Measurements in Stool samples
6 secondary outcomes
Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
Time frame: Comparison between baseline and month 3
Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
Time frame: Comparison between baseline and month 12
Histological Healing Assessed by Geboes Score
Time frame: Comparison between baseline and month 3
Histological Healing Assessed by Nancy Histological Index
Time frame: Comparison between baseline and month 3
Histological Healing Assessed by Geboes Score
Time frame: Comparison between baseline and month 12
Histological Healing Assessed by Nancy Histological Index
Time frame: Comparison between baseline and month 12
Results and safety
The study was stopped early (reason given: We were able to test our hypothesis using the current data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Anthony BUISSON, MD, PhD principal investigator
- CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum and fecal measurements in people with Moderate to Severe Ulcerative Colitis, run by University Hospital, Clermont-Ferrand 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 10 inclusion and 3 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 17 Jun 2026. 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: We were able to test our hypothesis using the current data). 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?
Serum measurements: CHI3L1 and NGAL-MMP9 (time frame: Serum change from baseline to month 3). The study lists 8 primary outcomes in all. 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 17 Jun 2026.