Evaluation of Feconomics for Diagnosis of Intestinal Parasitic Infections

Evaluation of Feconomics Versus Traditional Techniques for Diagnosis of Intestinal Parasitic Infections

People of all ages are affected by intestinal parasitic infections(IPIs) ; however, children are the most commonly affected, which is linked to their poor hygienic practices, and weak immune status. In children, IPIs are associated with malabsorption, weight loss, anemia, poor growth rate, learning difficulties, mental retardation and intellectual problems . The difficulty of diagnosis is the main problem in the control of intestinal parasitic infections. The choice of a particular technique is usually influenced by affordability, simplicity, cost, sensitivity in addition to the level of technical skills involved. Microscopic examination remains the cornerstone of parasitological diagnosis which is time consuming and requires an experienced observer to identify the organism. Formalin-ether sedimentation technique is commonly used in laboratories owing to its ability to isolate a large variety of parasites. However, it's a labor intensive procedure and is usually associated with hazards of using the inflammable lipid solvents. The drawbacks of the previous techniques have encouraged the development of commercial products such as Feconomics which is a new ready to use kit for concentration of stool samples in parasitological diagnosis.

The aim of the study is :

evaluation of the efficacy of Feconomics technique in comparison to traditional techniques i.e., direct smear and formalin ethyl acetate sedimentation technique for the diagnosis of intestinal parasites in school children.

Study Overview

• Status: Not yet recruiting
• Conditions: Intestinal Parasitic Infection

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Shorouk Nasser Mahmoud, Demonstrator; Phone Number: 02 01063778617; Email: shouroknasser@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

samples will be collected from school children whose age is between 6-12 from different locations (cities and village).

Description

Inclusion Criteria:

• school children whose age is between 6-12 years

Exclusion Criteria:

• children taking anti-parasitic drugs within the previous two weeks of stool sample collection .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the efficacy of Feconomics technique which is a new ready to use kit for concentration of stool samples , for diagnosis of intestinal parasitic infections in children	Comparing the sensitivity and specificity with traditional techniques i.e., direct smear and formalin ethyl acetate sedimentation technique for diagnosis of intestinal parasitic infections by examining stool samples from 100 patients, the number of cases with any intestinal parasite will be recorded.	6 months following the startpoint of the study

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Infections; Communicable Diseases; Parasitic Diseases; Intestinal Diseases, Parasitic
• Other Study ID Numbers: soh-med-22-04-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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