Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis

NCT04818788 | Unknown

• 1 other identifier: ulcerative colitis
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Biological Drug 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• patients (males and females at the age between 18 and 55 years) of ulcerative colitis indicated to biological therapy

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Bertani L, Rossari F, Barberio B, Demarzo MG, Tapete G, Albano E, Baiano Svizzero G, Ceccarelli L, Mumolo MG, Brombin C, de Bortoli N, Bellini M, Marchi S, Bodini G, Savarino E, Costa F. Novel Prognostic Biomarkers of Mucosal Healing in Ulcerative Colitis Patients Treated With Anti-TNF: Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio. Inflamm Bowel Dis. 2020 Sep 18;26(10):1579-1587. doi: 10.1093/ibd/izaa062.

  PMID: 32232392 BACKGROUND

• Magro F, Lopes SI, Lopes J, Portela F, Cotter J, Lopes S, Moreira MJ, Lago P, Peixe P, Albuquerque A, Rodrigues S, Silva MR, Monteiro P, Lopes C, Monteiro L, Macedo G, Veloso L, Camila C, Afonso J, Geboes K, Carneiro F; Portuguese IBD group [GEDII]. Histological Outcomes and Predictive Value of Faecal Markers in Moderately to Severely Active Ulcerative Colitis Patients Receiving Infliximab. J Crohns Colitis. 2016 Dec;10(12):1407-1416. doi: 10.1093/ecco-jcc/jjw112. Epub 2016 May 25.

  PMID: 27226417 BACKGROUND

• Bertani L, Blandizzi C, Mumolo MG, Ceccarelli L, Albano E, Tapete G, Baiano Svizzero G, Zanzi F, Coppini F, de Bortoli N, Bellini M, Morganti R, Marchi S, Costa F. Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study. Clin Transl Gastroenterol. 2020 May;11(5):e00174. doi: 10.14309/ctg.0000000000000174.

  PMID: 32677804 BACKGROUND

• Okba AM, Amin MM, Abdelmoaty AS, Ebada HE, Kamel AH, Allam AS, Sobhy OM. Neutrophil/lymphocyte ratio and lymphocyte/monocyte ratio in ulcerative colitis as non-invasive biomarkers of disease activity and severity. Auto Immun Highlights. 2019 May 15;10(1):4. doi: 10.1186/s13317-019-0114-8. eCollection 2019 Dec.

  PMID: 32257060 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Abdallah Abdelfadil, specialist

CONTACT

01015549991; abdallah.zidan1990@gmail.com

Essam Abdelmohsen, professor

CONTACT

01097510010; essamabdelmohsen@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: internal medicine physician

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 26, 2021
• Study Start: April 1, 2021
• Primary Completion: April 20, 2022
• Study Completion: June 1, 2022
• Last Updated: March 29, 2021

Record last verified: 2021-03