Early Changes in Inflammatory Indices and Healing in IBD
Early Kinetic Changes in Blood-Based Inflammatory Indices as Predictors of Endoscopic and Histological Healing in Patients With Inflammatory Bowel Disease
This prospective observational study aims to evaluate early changes in blood-based inflammatory indices during the first 4 weeks after treatment initiation or escalation and their relation to endoscopic and histological healing at 12 to 16 weeks in adult patients with inflammatory bowel disease.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Objective assessment of treatment response is important in inflammatory bowel disease. This prospective cohort study will include adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy.
Blood-based inflammatory indices will be assessed at baseline and at 4 weeks. Endoscopic and histological outcomes will be evaluated at approximately 12 to 16 weeks.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Yehia M Alaa, Resident
- Telefonnummer: 01552751879
- E-Mail: Yehia.18313599@med.aun.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.
Beschreibung
Inclusion Criteria:
- Age 18 years or older
- Confirmed diagnosis of ulcerative colitis or Crohn's disease
- Objective evidence of active disease at baseline
- Planned initiation or escalation of IBD treatment
- Baseline CBC with differential, CRP, and serum albumin available
- Planned follow-up assessment at approximately 12-16 weeks
- Planned follow-up colonoscopy with mucosal biopsies at approximately 12-16 weeks
- Written informed consent
Exclusion Criteria:
- Active infection
- Recent major surgery
- Malignancy
- Hematological malignancy or disorder substantially altering leukocyte or platelet counts
- Significant uncontrolled liver disease
- Severe renal disease expected to substantially affect inflammatory markers
- Recent blood transfusion
- Pregnancy
- Concomitant autoimmune inflammatory disease
- Systemic corticosteroids used for another indication
- Acute severe infection around the time of blood sampling
- Inadequate follow-up or missing essential data
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
Single cohort: Adult IBD Patients
Adult patients with ulcerative colitis or Crohn's disease who are starting or escalating medical therapy and will be followed for early changes in inflammatory indices and later endoscopic and histological outcomes. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of patients with endoscopic healing
Zeitfenster: 12 to 16 weeks
|
Proportion of patients achieving endoscopic healing at follow-up, defined as Mayo Endoscopic Score = 0 in ulcerative colitis or SES-CD < 3 in Crohn's disease. |
12 to 16 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Proportion of patients with histological healing
Zeitfenster: 12 to 16 weeks
|
Proportion of patients achieving histological healing based on histopathological assessment of mucosal biopsies. |
12 to 16 weeks
|
|
Mean change in neutrophil-to-lymphocyte ratio
Zeitfenster: Baseline and at 4 weeks
|
Mean change in neutrophil-to-lymphocyte ratio (NLR) from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean change in C-reactive protein
Zeitfenster: Baseline and at 4 weeks
|
Mean change in C-reactive protein (CRP) level from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean change in CRP-to-albumin ratio
Zeitfenster: Baseline and at 4 weeks
|
Mean change in CRP-to-albumin ratio (CAR) from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean change in systemic immune-inflammation index
Zeitfenster: Baseline and at 4 weeks
|
Mean change in systemic immune-inflammation index (SII) from baseline to 4 weeks. |
Baseline and at 4 weeks
|
|
Mean Mayo Endoscopic Score
Zeitfenster: 12 to 16 weeks
|
Mean Mayo Endoscopic Score in patients with ulcerative colitis (range 0-3, higher scores indicate more severe endoscopic activity). |
12 to 16 weeks
|
|
Mean SES-CD score
Zeitfenster: 12 to 16 weeks
|
Mean Simple Endoscopic Score for Crohn's Disease (SES-CD) (higher scores indicate more severe endoscopic activity). |
12 to 16 weeks
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Mohamed Z Hagez, prof, Internal Medicine Department, Assiut University Hospitals
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IBD-Indices-Assiut-2026
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .