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

NCT07653750 | Terminated

• 2 other identifiers: CHU-3982017-A02918-45
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score

  Comparison between baseline and month 3

• Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score

  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

Study Arms (1)

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.

Biological: Serum and fecal measurements

Interventions

Serum and fecal measurements BIOLOGICAL

* Serum measurements: NGAL-MMP9 and CHI3L1 * Fecal measurements: Calprotectin, CHI3L1 and MMP9

Patients affected by an ulcerative colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pregnant or breastfeeding woman
• Patients who have total coloproctectomy with ileo-anal anastomosis
• Acute Severe Ulcerative Colitis (ASUC)
• Persons under guardianship, trusteeship or imprisonment

You may not qualify if:

• Patient wishing to discontinue participation in the study for any reason
• Study exit at the investigator's discretion
• Pregnancy Discovery

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Anthony BUISSON, MD, PhD

  - CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants (patients with an ulcerative colitis) receive the same intervention : serum measurements (NGAL-MMP9, CHI3L1) and fecal measurements (Calprotectin, CHI3L1, MMP9).

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: June 17, 2026
• Study Start: June 25, 2021
• Primary Completion: June 9, 2026
• Study Completion: June 9, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)