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Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Withdrawn
Phase 4

Conditions

Helminth Infection

Treatments

Drug: Delayed treatment
Drug: Albendazole
Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT03032042
17-0101

Details and patient eligibility

About

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.

Sex

All

Ages

Under 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

0 participants in 4 patient groups

albendazole at day 0, azithromycin at day 7
Experimental group
Treatment:
Drug: Albendazole
azithromycin at day 0, albendazole at day 7
Experimental group
Treatment:
Drug: Azithromycin
albendazole at day 0, azithromycin at day 0
Experimental group
Treatment:
Drug: Albendazole
Drug: Azithromycin
Delayed treatment
Other group
Description:
albendazole at day 7, azithromycin at day 7
Treatment:
Drug: Delayed treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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