Serum Lactate and Ulcerative Colitis

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Diagnostic Test: serum lactate

• Registration Number: NCT05876494
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-05-25
• Study Start: 2023-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with ulcerative colitis	serum lactate	any patients with ulcerative colitis

Primary Outcome Measures

Name	Time	Method
Accuracy (%) of serum lactate in prediction the acute flare of ulcerative colitis	one year	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

Trial Locations

Locations (1)

Ahmed Mohammed Abu-Elfatth; 🇪🇬 Assiut, Egypt