Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis

Study Overview
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Brief Summary
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Investigators aimed at investigating the prediction ability of faecal calprotectin to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy Investigators aimed to evaluate the prediction ability of NLR, PLR and MLR to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy. Investigators evaluate the histological remission in ulcerative colitis patients receiving biological therapy in Assuit university hospital.

Detailed Description
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Ulcerative colitis (UC) is a chronic relapsing disease that involves the colorectal mucosa. Over the years, the therapeutic target has been upgraded from the resolution of symptoms to deep remission to prevent relapses and complications. The primary therapeutic target to be achieved in patients with UC is both clinical and endoscopic remission . The assessment of histological inflammation has emerged as a promising endpoint in UC . However, the link between histological disease activity and other measures of clinical disease activity is not yet well established . Some authors suggest that the presence of histological inflammation is a better predictor of future clinical relapse than endoscopic activity . Several studies showed that patients with residual microscopic active inflammation seem to be more prone to relapse when compared with patients with normal histology . Calprotectin is a 36-kDa calcium- and zinc-binding protein, which represents approximately 60% of soluble proteins of granulocyte cytoplasm . Fecal calprotectin (FC) is strongly correlated with both MES and Ulcerative Colitis Endoscopic Score (9, 10). In previous studies, FC was shown to be helpful in predicting sustained clinical remission and mucosal healing during anti-TNF treatment, particularly with IFX and ADA. However, no investigations have been performed to evaluate the predictive value of FC in terms of mucosal healing in a prospective cohort of patients with UC treated with biological therapy. Based on the above background, the aim of the present prospective study is to identify a reliable biomarker able to predict therapeutic effectiveness in UC . Ulcerative colitis (UC) is a chronic relapsing disease characterized by a neutrophil-mediated inflammation of the gut. Indeed, European Crohn and Colitis Organization guidelines have highlighted how the grade of neutrophilic infiltration is necessary for the diagnosis of this pathological condition and for the evaluation of histological activity. Thus, colonoscopy is necessary to collect mucosal biopsies and assess neutrophilic infiltration for the diagnosis and during follow-up to evaluate treatment response and predict long-term outcome, although histological healing is still debated. However, colonoscopy is an invasive, costly, and not always well-tolerated examination for patients. Apart from endoscopic interventions, disease severity can be also assessed using less-invasive biomarkers, including blood count. In these regard the investigators aimed to investigate the ability of prediction of hematological indices including (PLR, NLR and MLR) and fecal calprotectin to predict histological remission in ulcerative colitis patients receiving biological therapy .

Official Title
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Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Biological Drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 24 patients (males and females at the age between 18 and 55 years) of ulcerative colitis indicated to biological therapy Exclusion Criteria: - Ulcerative colitis pregnant women Patient receiving biological therapy for extra intestinal manifestation Patients on corticosteroids more than 20 mg as it affects leucocytic count Patients under the age of 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Biological Drug|we will give biological drugs to indicated ulcerative colitis patients and we will investigate the predictive ability of fecal calprotectin and hematological indices to histological remission|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological remission in ulcerative colitis patients receiving biological therapy | Assessment of histological remission by using Geboes score index Histological remission was defined as Geboes index ≤ 3.0.15 .The Geboes index consists of a scoring system with five distinctive grades [each with subgrades], corresponding to different aspects of inflammatory activity in the mucosa. Grade 0 corresponds to structural [architectural] change, grade 1 to chronic inflammatory infiltrate, grade 2 to lamina propria eosinophils [2A] and neutrophils [2B], grade 3 to neutrophils in the epithelium, grade 4 to crypt destruction, and grade 5 to erosion or ulceration. Higher subgrade scores reflect a more severe condition. | one year | 
| Assessment of fecal calprotectin level in ulcerative colitis patients receiving biological therapy | measured by quantative enzyme immuno assay μg/g. | one year | 
| Assessment of the level of PLR, NLR , MLR in ulcerative colitis patients receiving biological therapy | by extraction of the values of blood counts in particular WBC and platelet count | one year | 
| Ability of hematological indices and fecal calprotectin to predict histological remission | by correlate the level of hematological indices and fecal cal peotectin with histological remission | one year |