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Not Yet RecruitingNCT06533696

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
94 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

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)

Conditions

Timeline

Start date
2024-07-01
Primary completion
2025-07-01
Completion
2025-12-01
First posted
2024-08-01
Last updated
2024-08-01

Source: ClinicalTrials.gov record NCT06533696. Inclusion in this directory is not an endorsement.