Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

Study Overview
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Brief Summary
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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
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Helminth Infection

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Albendazole
* Drug: Delayed treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all children 0 to 5 (up to 6th birthday) Exclusion Criteria: individuals with a macrolide allergy refusal of parent/guardian

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: albendazole at day 0, azithromycin at day 7<br> | Drug: Albendazole<br> <br> |
| Experimental: azithromycin at day 0, albendazole at day 7<br> | Drug: Azithromycin<br> <br> |
| Experimental: albendazole at day 0, azithromycin at day 0<br> | Drug: Azithromycin<br> <br> Drug: Albendazole<br> <br> |
| Other: Delayed treatment<br>albendazole at day 7, azithromycin at day 7 | Drug: Delayed treatment<br>* Albendazole+Azithromycin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial diversity in the intestinal microbiomes of children aged 1-60 months | 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 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5 | 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. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal microbiome, soil-transmitted helminths, mass drug administration