Serum Lactate and Ulcerative Colitis

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05876494
• Collaborator: (none)
• Enrollment: 137
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 19.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	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 Design

• Study Type: Observational
• Anticipated Enrollment: 137 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Serum Lactate and Mean Platelet Volume as Predicators for Acute Exacerbation in Patients With Ulcerative Colitis
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
patients with ulcerative colitis any patients with ulcerative colitis	Diagnostic Test: serum lactate; assessment of serum lactate and mean platelets volume

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Mohammed Abu-Elfatth	Assiut		Egypt	71515

Sponsors and Collaborators

• Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Ahmed Mohammed Abu Elfatth, Lecturer of Tropical Medicine and Gastroenterology, Assiut University
• ClinicalTrials.gov Identifier: NCT05876494
• Other Study ID Numbers: Alaa Esam
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of May 25, 2023