Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02918-45 | Other Identifier | 2017-A02918-45 |
Not provided
Not provided
We were able to test our hypothesis using the current data
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum and fecal measurements | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum measurements: CHI3L1 and NGAL-MMP9 | Measurements in Blood samples | Serum change from baseline to month 3 |
| Serum measurements: CHI3L1 and NGAL-MMP9 | Measurements in Blood samples | Serum change from baseline to month 6 |
| Serum measurements: CHI3L1 and NGAL-MMP9 | Measurements in Blood samples | Serum change from baseline to month 9 |
| Serum measurements: CHI3L1 and NGAL-MMP9 | Measurements in Blood samples | Serum change from baseline to month 12 |
| Fecal measurements: CHI3L1, MMP9 | Measurements in Stool samples | Comparison between baseline and month 3 |
| Fecal measurements: CHI3L1, MMP9 | Measurements in Stool samples | Comparison between baseline and month 6 |
| Fecal measurements: CHI3L1, MMP9 | Measurements in Stool samples | Comparison between baseline and month 9 |
| Fecal measurements: CHI3L1, MMP9 | Measurements in Stool samples | Comparison between baseline and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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)). |
Not provided
Inclusion Criteria:
Non Inclusion Criteria :
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony BUISSON, MD, PhD | - CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | Auvergne | 63003 | France |
Not provided
All participants (patients with an ulcerative colitis) receive the same intervention : serum measurements (NGAL-MMP9, CHI3L1) and fecal measurements (Calprotectin, CHI3L1, MMP9).
Not provided
Not provided
No masking.
Not provided
| 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)). | Comparison between baseline and month 12 |
| 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 |
| Histological Healing Assessed by Geboes Score | Comparison between baseline and month 12 |
| Histological Healing Assessed by Nancy Histological Index | Comparison between baseline and month 12 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided