Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

Helminth Infection Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03032042
• Other study ID #: 17-0101
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: June 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• individuals with a macrolide allergy
• refusal of parent/guardian

Related Conditions & MeSH terms

• Helminth Infection
• Helminthiasis

Intervention

Drug:
• Azithromycin

• Albendazole

• Delayed treatment
Albendazole+Azithromycin

Locations

Country	Name	City	State
Ethiopia	The Carter Center Ethiopia	Addis Ababa

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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