Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05856721
Collaborator
(none)
200
1
2
12
16.6

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: stool analysis
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: cases group

One hundred patients with liver cirrhosis and GIT complaints

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.

Active Comparator: control group

One hundred patients with GIT complaints but not have any cormobidity

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.

Outcome Measures

Primary Outcome Measures

  1. Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients [12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nada Nady Abdelaal, residant at Tropical Medicine & Gastroenterology departmrnt sohag university, Sohag University
ClinicalTrials.gov Identifier:
NCT05856721
Other Study ID Numbers:
  • Soh-Med-23-04-13MS
First Posted:
May 12, 2023
Last Update Posted:
May 12, 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:

Study Results

No Results Posted as of May 12, 2023