A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia Lamblia in Children, Sohag

The present study was done to evaluate the efficacy of Human anti Giardia lamblia antibody (ELISA) kitst in comparison to direct microscopy in the diagnosis of G. lamblia in stool specimens from immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Giardia Lamblia Infection

Detailed Description

Giardia duode- nalis is an intestinal protozoan parasite with a worldwide distribu- tion in human and

animals ( Dixon BR.,2021)

According to WHO reports in 2010, giardiasis is estimated to cause approximately 28.2 million cases of

diarrhea (WHO.,2015)

The prevalence of giardiasis is 2 to 5% in developed countries and 20 to 30% in developing countries in children (Luis et al.,2017)

The fecal-oral route is the main transmission mode of G. duodenalis . Drinking water, food and

vegetables contaminated by G. duodenalis cysts are the main sources of transmission ( Adam Rodney.,2021)

The common clinical manifestations of giardiasis include greasy diarrhea (steatorrhea), nausea,

vomiting, abdominal bloating, cramps, malabsorption and weight loss (Taghipour et al .,2022)

The detection and diagnosis of giardiasis present challenges for physicians, especially in regions distant

from high-prevalence areas where a substantial number of asymptomatic patients further complicate

prevalence determination. Symptoms, which closely mimic those of other parasitic diseases, can

confound clinicians, potentially leading to the prescription of ineffective remedies (Escobedo .et al .,2018)

Several different diagnostic systems have been described for the diagnosis of giardiasis: among them are

microscopic diagnosis, molecular methods, and immunoassays such as ELISA for the detection

of Giardia antigen or anti-Giardia antibodies, and Direct Fluorescence Antibody (DFA) test, which

detects antigens present on the cell wall of Giardia cysts ( Sadaka et al .,2015)

The early accurate diagnosis of giardiasis is important for the successful treatment and prevention of

diseases. The routine laboratory diagnosis is performed for the detection of trophozoites or cysts by

microscopic examination of at least three stool samples collected independently (.Uehlinger et al.,2017)

This diagnosis depends upon the times of sampling, patient compliance, application of concentration

methods, and the expertise of the technologists. Furthermore, in recent years, other methods, such as

ELIZA and molecular techniques are used mainly for diagnostic or research purposes. The sensitivity

and specificity of all diagnostic methods can be improved by including alternative diagnostic procedures

that are more rapid and reliable ( Kosack et al.,2017)

The recently licensed commercially available enzyme-linked immunosorbent assay (ELISA) kits are

found to be rapid and effective methods to diagnose Giardia infection in patients with gastrointestinal

symptomatology by detecting G. lamblia associated antigens in stool (Jahan et al.,2014)

• Study Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: Arwa yo Abdelsabour, demonstrator; Phone Number: 01007407743; Email: arwah.yousef@med.sohag.edu.eg
• Study Contact Backup: Name: Hanaa Ah El-Hady, Professor; Phone Number: 01005692515

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms with any age and sex group

Description

Inclusion Criteria:

• Immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms with any age and sex group

Exclusion Criteria:

• patients taking anti parasitic treatment within the previous two weeks of stool sample collection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
immunocompromised; immunocompromised cancer, renal failure and undernourished patients
immunocompetent; exclude cancer, renal failure patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia lamblia in Children, Sohag	evaluate the efficacy of Human anti Giardia lamblia antibody (ELISA) kitst in comparison to direct microscopy in the diagnosis of G. lamblia in stool specimens from immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms.	1 year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Parasitic Diseases; Protozoan Infections; Giardiasis
• Other Study ID Numbers: Soh-Med-24-06-21MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No