Serum Lactate and Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876494
• Other study ID #: Alaa Esam
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Ahmed M Abu-Elfatth
• Phone: +18677791
• Email: ahmed111[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 137
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• serum lactate
assessment of serum lactate and mean platelets volume

Locations

Country	Name	City	State
Egypt	Ahmed Mohammed Abu-Elfatth	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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