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

16. juni 2026 opdateret af: University Hospital, Clermont-Ferrand
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: Serum and fecal measurements
  • Serum measurements: NGAL-MMP9 and CHI3L1
  • Fecal measurements: Calprotectin, CHI3L1 and MMP9

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum measurements: CHI3L1 and NGAL-MMP9
Tidsramme: Serum change from baseline to month 3
Measurements in Blood samples
Serum change from baseline to month 3
Serum measurements: CHI3L1 and NGAL-MMP9
Tidsramme: Serum change from baseline to month 6
Measurements in Blood samples
Serum change from baseline to month 6
Serum measurements: CHI3L1 and NGAL-MMP9
Tidsramme: Serum change from baseline to month 9
Measurements in Blood samples
Serum change from baseline to month 9
Serum measurements: CHI3L1 and NGAL-MMP9
Tidsramme: Serum change from baseline to month 12
Measurements in Blood samples
Serum change from baseline to month 12
Fecal measurements: CHI3L1, MMP9
Tidsramme: Comparison between baseline and month 3
Measurements in Stool samples
Comparison between baseline and month 3
Fecal measurements: CHI3L1, MMP9
Tidsramme: Comparison between baseline and month 6
Measurements in Stool samples
Comparison between baseline and month 6
Fecal measurements: CHI3L1, MMP9
Tidsramme: Comparison between baseline and month 9
Measurements in Stool samples
Comparison between baseline and month 9
Fecal measurements: CHI3L1, MMP9
Tidsramme: Comparison between baseline and month 12
Measurements in Stool samples
Comparison between baseline and month 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
Tidsramme: 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)).
Comparison between baseline and month 3
Endoscopic Mucosal Healing Assessed by Mayo Endoscopic Score
Tidsramme: Comparison between baseline and month 12
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
Tidsramme: Comparison between baseline and month 3
Comparison between baseline and month 3
Histological Healing Assessed by Nancy Histological Index
Tidsramme: Comparison between baseline and month 3
Comparison between baseline and month 3
Histological Healing Assessed by Geboes Score
Tidsramme: Comparison between baseline and month 12
Comparison between baseline and month 12
Histological Healing Assessed by Nancy Histological Index
Tidsramme: Comparison between baseline and month 12
Comparison between baseline and month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Efterforskere

  • Ledende efterforsker: Anthony BUISSON, MD, PhD, - CHU de Clermont-Ferrand, Service d'Hépatogastroentérologie

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juni 2021

Primær færdiggørelse (Faktiske)

9. juni 2026

Studieafslutning (Faktiske)

9. juni 2026

Datoer for studieregistrering

Først indsendt

29. juni 2018

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHU-398
  • 2017-A02918-45 (Anden identifikator: 2017-A02918-45)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Moderat til svær colitis ulcerosa

Kliniske forsøg med Serum and fecal measurements

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