Serum Lactate and Ulcerative Colitis | NCT05876494

Studies
Serum Lactate and Ulcerative Colitis

NCT05876494

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 20, 2023Actual

Enrollment

137Estimated

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

serum lactate

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 7, 2023

First Submission Date that Met QC Criteria

May 24, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 20, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Mohammed Abu Elfatth, Lecturer of Tropical Medicine and Gastroenterology, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

137Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with ulcerative colitis		any patients with ulcerative colitis	Diagnostic Test: serum lactate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum lactate	Diagnostic Test	assessment of serum lactate and mean platelets volume	patients with ulcerative colitis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed M Abu-Elfatth	Contact	+18677791		ahmed111@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed M Abu-Elfatth	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Mohammed Abu-Elfatth	Recruiting	Asyut		71515	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24696607	Background	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.

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases