Intestinal Parasitic InfectionNCT05360472
Evaluation of Feconomics for Diagnosis of Intestinal Parasitic Infections
An observational study of Intestinal Parasitic Infection, run by Sohag University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Parasitic Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: samples will be collected from school children whose age is between 6-12 from different locations (cities and village).
Who may be able to join
- school children whose age is between 6-12 years
Who cannot join
- children taking anti-parasitic drugs within the previous two weeks of stool sample collection .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Intestinal Parasitic Infection
- Medical subject headings
- Intestinal Diseases, Parasitic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months following the startpoint of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Parasitic InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorouk Nasser Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360472
- Sponsor's protocol ID
- soh-med-22-04-17
- Status last verified
- Jun 2022
- First submitted
- 28 Apr 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feconomics Versus Traditional Techniques for Diagnosis of Intestinal Parasitic Infections
- ClinicalTrials.gov ID
- NCT05360472
- Acronym / sponsor ID
- soh-med-22-04-17
- Conditions
- Intestinal Parasitic Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- samples will be collected from school children whose age is between 6-12 from different locations (cities and village).
Key inclusion criteria (1 listed)
- school children whose age is between 6-12 years
Key exclusion criteria (1 listed)
- children taking anti-parasitic drugs within the previous two weeks of stool sample collection .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 6 months following the startpoint of the study
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Parasitic Infection, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shorouk Nasser Mahmoud, Demonstrator (01063778617 ext. 02, shouroknasser@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months following the startpoint of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.