Helminth Infection
Conditions
Keywords
intestinal microbiome, soil-transmitted helminths, mass drug administration
Brief summary
Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted PCR testing to next generation sequencing techniques. In addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. Rectal swabs are more efficient and may result in higher participation. In this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. The investigators will compare the PCR test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. In addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.
Interventions
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* all children 0 to 5 (up to 6th birthday)
Exclusion criteria
* individuals with a macrolide allergy * refusal of parent/guardian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial diversity in the intestinal microbiomes of children aged 1-60 months | Day 7 | Microbiota diversity in the intestinal microbiomes of children aged 1-60 months in azithromycin-treated, albendazole-treated, azithromycin+albendazole-treated and delayed treatment arms using phylogenetic distance measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5 | Day 7 | The investigators use PCR to identify soil transmitted helming infections in rectal swab samples and bulk stool sample from the same child. Using the bulk stool sample as the gold standard, the investigators will calculate the sensitivity, specificity, PPV, and NPV of the rectal swabs for detecting the various helminth infections. |
Countries
Ethiopia
Outcome results
None listed