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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yehia M Alaa, Resident
- Telefonnummer: 01552751879
- E-mail: Yehia.18313599@med.aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adult patients with ulcerative colitis or Crohn's disease starting or escalating medical therapy at the Gastroenterology and Hepatology Unit, Assiut University.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients with endoscopic healing
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients with histological healing
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Mohamed Z Hagez, prof, Internal Medicine Department, Assiut University Hospitals
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IBD-Indices-Assiut-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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