NCT06533696

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Giardia Lamblia Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

immunocompromised

immunocompromised cancer, renal failure and undernourished patients

immunocompetent

exclude cancer, renal failure patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Giardiasis

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Arwa yo Abdelsabour, demonstrator

CONTACT

01007407743arwah.yousef@med.sohag.edu.eg

Hanaa Ah El-Hady, Professor

CONTACT

01005692515

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator at medical parasitology department at faculty of medicine sohag

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 1, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

August 1, 2024

Record last verified: 2024-07