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Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT04818788
Recruitment Status : Not yet recruiting
First Posted : March 26, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Abdallah Abdelfadil Abdelal, Assiut University

Brief Summary:

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.


Condition or disease Intervention/treatment
Ulcerative Colitis Drug: Biological Drug

Detailed Description:

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 .

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Histological remission in ulcerative colitis patients receiving biological therapy [ Time Frame: one year ]
    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.

  2. Assessment of fecal calprotectin level in ulcerative colitis patients receiving biological therapy [ Time Frame: one year ]
    measured by quantative enzyme immuno assay μg/g.

  3. Assessment of the level of PLR, NLR , MLR in ulcerative colitis patients receiving biological therapy [ Time Frame: one year ]
    by extraction of the values of blood counts in particular WBC and platelet count

  4. Ability of hematological indices and fecal calprotectin to predict histological remission [ Time Frame: one year ]
    by correlate the level of hematological indices and fecal cal peotectin with histological remission



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

our study will include ulcerative colitis patients who are indicated to biological therapy at gastro enterology unit in internal medicine department at Assuit university during the period of April 2021 to April 2022 and we will do the following to every patient :

full history including drug history full examination colonoscopy and histological examination before the biological therapy and after 8 weeks and after 25 weeks and after 52 weeks ESR , CRP , Fecal calprotectin and CBC including NLR, PLR and MLR before starting biological therapy and after 8 weeks and after 25 weeks and after 52 weeks

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818788


Contacts
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Contact: Abdallah Abdelfadil, specialist 01015549991 abdallah.zidan1990@gmail.com
Contact: Essam Abdelmohsen, professor 01097510010 essamabdelmohsen@aun.edu.eg

Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: Abdallah Abdelfadil Abdelal, internal medicine physician, Assiut University
ClinicalTrials.gov Identifier: NCT04818788    
Other Study ID Numbers: ulcerative colitis
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases