Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
Primary Purpose
Liver Cirrhosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stool analysis
Sponsored by
About this trial
This is an interventional screening trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria: Patients diagnosed to have liver cirrhosis with or without hepatocellular carcinoma. Exclusion Criteria: . Cirrhotic patients with renal impairment. . Cirrhotic patients with cardiac diseases.
Sites / Locations
- Sohag university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
cases group
control group
Arm Description
One hundred patients with liver cirrhosis and GIT complaints
One hundred patients with GIT complaints but not have any cormobidity
Outcomes
Primary Outcome Measures
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients
Detection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity.
To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05856721
Brief Title
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
Official Title
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic hepatic illness is one of the most serious health issues . Liver cirrhosis as the latest phase of chronic liver disease causes a disorder called cirrhosis-associated immune dysfunction syndrome (CAIDS) . Cirrhosis comes to be a systemic disease, with several organ disorders. At this phase, patients become highly vulnerable to various infections because of CAIDS, which comprises both innate and adaptive immunity). Patients with hepatic cirrhosis and ascites are more liable to other complications of liver disease, including hyponatremia, refractory ascites, or hepatorenal syndrome (HRS) . Liver cirrhotic patients are considered to be as immunosuppressed and are vulnerable to a different species of entero-parasites .
Intestinal parasitic diseases have been reported in association with diabetes mellitus (DM) which is considered a predisposing factor to infection in cirrhotic patients . Immunosuppression among DM cases is due to increased blood glucose levels, which modifies several immune responses and this renders the body susceptible to various opportunistic infections comprising parasitic infections
Intestinal parasites such as Blastocystis hominis, Cryptosporidium spp., Isospora belli, Cyclospora cayetanensis, and Microsporidia have appeared as significant opportunistic parasites that are responsible for severe illness in immunocompromised patients , subsequently, patients suffer from severe morbidity and high mortality).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cases group
Arm Type
Active Comparator
Arm Description
One hundred patients with liver cirrhosis and GIT complaints
Arm Title
control group
Arm Type
Active Comparator
Arm Description
One hundred patients with GIT complaints but not have any cormobidity
Intervention Type
Diagnostic Test
Intervention Name(s)
stool analysis
Intervention Description
Detection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity.
To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients.
Primary Outcome Measure Information:
Title
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients
Description
Detection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity.
To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed to have liver cirrhosis with or without hepatocellular carcinoma.
Exclusion Criteria:
. Cirrhotic patients with renal impairment.
. Cirrhotic patients with cardiac diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada N Abdelaal, residant
Phone
01064067855
Email
nadanady@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa N Mohamed, professor
Facility Information:
Facility Name
Sohag university hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20558165
Citation
Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.
Results Reference
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PubMed Identifier
26192220
Citation
Bernardi M, Moreau R, Angeli P, Schnabl B, Arroyo V. Mechanisms of decompensation and organ failure in cirrhosis: From peripheral arterial vasodilation to systemic inflammation hypothesis. J Hepatol. 2015 Nov;63(5):1272-84. doi: 10.1016/j.jhep.2015.07.004. Epub 2015 Jul 17.
Results Reference
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PubMed Identifier
21397731
Citation
Bonnel AR, Bunchorntavakul C, Reddy KR. Immune dysfunction and infections in patients with cirrhosis. Clin Gastroenterol Hepatol. 2011 Sep;9(9):727-38. doi: 10.1016/j.cgh.2011.02.031. Epub 2011 Mar 11.
Results Reference
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PubMed Identifier
25698851
Citation
El-Shazly LB, El-Faramawy AA, El-Sayed NM, Ismail KA, Fouad SM. Intestinal parasitic infection among Egyptian children with chronic liver diseases. J Parasit Dis. 2015 Mar;39(1):7-12. doi: 10.1007/s12639-013-0346-x. Epub 2013 Sep 3.
Results Reference
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Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
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