Clinical Trial: Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Francis I. Proctor Foundation

Current Primary Outcome: Microbial diversity in the intestinal microbiomes of children aged 1-60 months [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Francis I. Proctor Foundation

Dates:
Date Received: January 8, 2017
Date Started: January 2017
Date Completion: February 2018
Last Updated: January 23, 2017
Last Verified: January 2017