Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

• Status: Withdrawn
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Francis I. Proctor Foundation; University of California, San Francisco
• Treatments: Albendazole; Azithromycin

Criteria

Inclusion Criteria:

• all children 0 to 5 (up to 6th birthday)

Exclusion Criteria:

• individuals with a macrolide allergy

• refusal of parent/guardian