NCT03032042

Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Helminth Infection

Interventions

Type	Name	Description
DRUG	Azithromycin
DRUG	Albendazole
DRUG	Delayed treatment	Albendazole+Azithromycin

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-02-01
• Completion: 2018-02-01
• First posted: 2017-01-26
• Last updated: 2021-06-28

Locations

1 site across 1 country: Ethiopia