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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05856721
Other study ID # Soh-Med-23-04-13MS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2023
Est. completion date June 2024

Study information

Verified date May 2023
Source Sohag University
Contact Nada N Abdelaal, residant
Phone 01064067855
Email nadanady@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
stool analysis
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.

Locations

Country Name City State
Egypt Sohag university hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
12 months
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