Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
- Conditions
- Helminth Infection
- Interventions
- Registration Number
- NCT03032042
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- all children 0 to 5 (up to 6th birthday)
- individuals with a macrolide allergy
- refusal of parent/guardian
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description albendazole at day 0, azithromycin at day 7 Albendazole - Delayed treatment Delayed treatment albendazole at day 7, azithromycin at day 7 azithromycin at day 0, albendazole at day 7 Azithromycin - albendazole at day 0, azithromycin at day 0 Azithromycin - albendazole at day 0, azithromycin at day 0 Albendazole -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
The Carter Center Ethiopia
🇪🇹Addis Ababa, Ethiopia