Giardia Lamblia InfectionNCT06533696
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia Lamblia in Children, Sohag
An observational study of Giardia Lamblia Infection, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Giardia Lamblia Infection
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms with any age and sex group
Who may be able to join
- Immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms with any age and sex group
Who cannot join
- patients taking anti parasitic treatment within the previous two weeks of stool sample collection.
Trial locations and contacts
No sites are listed yet.
Hanaa Ah El-Hady, Professor contact
About this study
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.
Read the 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
- Giardia Lamblia Infection
- Medical subject headings
- Giardiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| immunocompromised | immunocompromised cancer, renal failure and undernourished patients | |
| immunocompetent | exclude cancer, renal failure patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giardia Lamblia 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-control
- Time perspective
- Other
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa youssif Abdelsabor, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533696
- Sponsor's protocol ID
- Soh-Med-24-06-21MS
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia Lamblia in Children, Sohag
- ClinicalTrials.gov ID
- NCT06533696
- Acronym / sponsor ID
- Soh-Med-24-06-21MS
- Conditions
- Giardia Lamblia Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunocompromised | – | –immunocompromised cancer, renal failure and undernourished patients |
| immunocompetent | – | –exclude cancer, renal failure patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms with any age and sex group
Key inclusion criteria (1 listed)
- Immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms with any age and sex group
Key exclusion criteria (1 listed)
- patients taking anti parasitic treatment 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
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia lamblia in Children, Sohag
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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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.
Hanaa Ah El-Hady, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Giardia Lamblia 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 1 Aug 2024. 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 Arwa yo Abdelsabour, demonstrator (01007407743, arwah.yousef@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia lamblia in Children, Sohag (time frame: 1 year). 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 1 Aug 2024.