Serum Lactate and Ulcerative Colitis

Serum Lactate and Mean Platelet Volume as Predicators for Acute Exacerbation in Patients With Ulcerative Colitis

Patients presenting with severe symptoms of ulcerative colitis (UC) require hospital admission for urgent assessment and therapy. Endoscopic examination of the rectum and/or distal colon is often performed to assess severity and obtain tissue for histopathologic evaluation, but this is often extended to full colonoscopy to assess the extent of bowel involvement. Full colonoscopy is hazardous in this setting

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Diagnostic test: serum lactate

Detailed Description

Biomarkers like erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) are used for monitoring the disease activity but present a low specificity and sensitivity in UC . There are fecal biomarkers with better performance for detecting disease activity in UC like fecal calprotectin and lactoferrin, however, are very expensive Platelets present granules with Interleukin 8 (IL-8) which is a potent neutrophil chemoattractant and its cytoplasm contains P-selectin that induces overproduction of superoxide and the formation of neutrophil-platelet aggregates, which are elevated in patients with UC. The inhibition of this aggregates suppress the appearance of colon inflammation

The mean platelet volume (MPV) is correlated to the UC activity as also the increase of white blood count (WBC) mainly neutrophils. The interaction of neutrophil-platelet is a possible explanation of the high prevalence of thrombosis in UC due to the formation of Neutrophil Extracellular Traps (NETs) through Toll-like receptor 4 (TLR-4)

• Study Type: Observational
• Enrollment (Estimated): 137

Contacts and Locations

• Study Contact: Name: Ahmed M Abu-Elfatth; Phone Number: +18677791; Email: ahmed111@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Ahmed Mohammed Abu-Elfatth
    • Contact: Ahmed M Abu-Elfatth; Phone Number: +18677791; Email: ahmed111@aun.edu.eg
    • Contact: Ahmed M Abu-Elfatth; Phone Number: 8677791; Email: ahmed111@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient who is above age of 18 years old and diagnosed to have UC based on combination between clinical, laboratory, radiological, endoscopic and/or histopathological data whatever the course of the disease

Description

Inclusion criteria:

Any patient who is above age of 18 years old and diagnosed to have UC based on combination between clinical, laboratory, radiological, endoscopic and/or histopathological data whatever the course of the disease Exclusion criteria

• Patients with inflammatory bowel disease (IBD) other than UC as those with Crohn's disease or microscopic colitis
• Pregnant patients with ulcerative colitis.
• Patients with UC who are under age of 18 years old
• Patient's refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with ulcerative colitis; any patients with ulcerative colitis	Diagnostic test: serum lactate; assessment of serum lactate and mean platelets volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy (%) of serum lactate in prediction the acute flare of ulcerative colitis	By using the receiver operator characteristics curve, we can determine the best cutoff point of serum lactate to predict the acute flare of ulcerative colitis	one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed M Abu-Elfatth, Assiut University

Publications and helpful links

General Publications

• Bennike T, Birkelund S, Stensballe A, Andersen V. Biomarkers in inflammatory bowel diseases: current status and proteomics identification strategies. World J Gastroenterol. 2014 Mar 28;20(12):3231-44. doi: 10.3748/wjg.v20.i12.3231.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Alaa Esam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No