Health Condition 1: A040- Enteropathogenic Escherichia coliinfection Health Condition 2: A041- Enterotoxigenic Escherichia coli infection
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Babycue private limited
Eligibility
Inclusion criteria
Inclusion criteria: The study targets children under 5 years of age as this group is vulnerable to diarrheal disease and associated antimicrobial resistance. Eligible participants must be able to provide a fresh stool sample at the time of enrolment to ensure the validity and reliability of the diagnostic evaluation. Informed consent will be obtained from parent or legal guardian to ensure ethical participation.
Exclusion criteria
Exclusion criteria: Exclusion of children with severe illness requiring hospitalisation is necessary to avoid confounding medical condition that could influence the study result. Participnts with chronic condition are excluded to minimize the variability in the health parameters that may interfere with the test performance. Additionally children who have received antibiotics in the past two weeks are excluded as antimicrobial exposure may alter gut flora or pathogen load, potentially affecting diagnostic accuracy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The lateral flow assay LFA will demonstrate high sensitivity and specificity in differentiating the bacterial and non bacterial causes of diarrhea in children under five when compared to the gold standard stool culture.Timepoint: LFA will be validated as the rapid easy to use and cost effective diagnostic tools suitable for the use in setting with limited laboratory infrastructure. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactManish Kumar Swain
Kalinga Institute of Medical Sciences
Outcome results
None listed