Study on Variation of Serum and Fecal Biomarkers After Treatment to Predict Mucosal Healing in Patients With Ulcerative Colitis (MIROIR)

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.

Study Overview

• Status: Terminated
• Conditions: Moderate to Severe Ulcerative Colitis
• Intervention / Treatment: Biological: Serum and fecal measurements

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients affected by an ulcerative colitis; Predict mucosal healing in patients with ulcerative colitis by measures on the variation of serum and fecal biomarkers after treatment.	Biological: Serum and fecal measurements; Serum measurements: NGAL-MMP9 and CHI3L1; Fecal measurements: Calprotectin, CHI3L1 and MMP9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)).	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Anthony BUISSON, MD, PhD, - CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): June 9, 2026
• Study Completion (Actual): June 9, 2026

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative colitis; Serum biomarkers; Mucosal healing; Fecal biomarkers; Histological healing; Chitinase 3-Like-1 (CHI3L1); Matrix metalloprotease type (MMP-9); NGAL-MMP9 complex
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CHU-398; 2017-A02918-45 (Other Identifier: 2017-A02918-45)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No