Moderate to Severe Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, Mucosal healing, Histological healing, Chitinase 3-Like-1 (CHI3L1), Matrix metalloprotease type (MMP-9), Serum biomarkers, Fecal biomarkers, NGAL-MMP9 complex
Brief 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. 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.
Interventions
BIOLOGICALSerum and fecal measurements
* Serum measurements: NGAL-MMP9 and CHI3L1 * Fecal measurements: Calprotectin, CHI3L1 and MMP9
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking.
Intervention model description
All participants (patients with an ulcerative colitis) receive the same intervention : serum measurements (NGAL-MMP9, CHI3L1) and fecal measurements (Calprotectin, CHI3L1, MMP9).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Pregnant or breastfeeding woman * Patients who have total coloproctectomy with ileo-anal anastomosis * Acute Severe Ulcerative Colitis (ASUC) * Persons under guardianship, trusteeship or imprisonment
Exclusion criteria
* Patient wishing to discontinue participation in the study for any reason * Study exit at the investigator's discretion * Pregnancy Discovery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum measurements: CHI3L1 and NGAL-MMP9 | Serum change from baseline to month 3 | Measurements in Blood samples |
| Fecal measurements: CHI3L1, MMP9 | Comparison between baseline and month 3 | Measurements in Stool samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score | Comparison between baseline and month 3 | 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)). |
| Histological Healing Assessed by Geboes Score | Comparison between baseline and month 3 | — |
| Histological Healing Assessed by Nancy Histological Index | Comparison between baseline and month 3 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAnthony BUISSON, MD, PhD
- CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie
Outcome results
None listed