Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: albendazole at day 0, azithromycin at day 7
|
Drug: Albendazole
|
| Experimental: azithromycin at day 0, albendazole at day 7
|
Drug: Azithromycin
|
| Experimental: albendazole at day 0, azithromycin at day 0
|
Drug: Azithromycin
Drug: Albendazole
|
| Other: Delayed treatment albendazole at day 7, azithromycin at day 7 |
Drug: Delayed treatment
Albendazole+Azithromycin
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- all children 0 to 5 (up to 6th birthday)
Exclusion Criteria:
-
individuals with a macrolide allergy
-
refusal of parent/guardian
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Carter Center Ethiopia | Addis Ababa | Ethiopia |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Jeremy Keenan, MD, MPH, F.I. Proctor Foundation, University of California San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-0101