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Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03032042
Recruitment Status : Withdrawn (We were not able to secure IRB approval in the timeline necessary to do this study.)
First Posted : January 26, 2017
Last Update Posted : May 14, 2020
Information provided by (Responsible Party):
Jeremy Keenan, Francis I. Proctor Foundation

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
Helminth Infection Drug: Azithromycin Drug: Albendazole Drug: Delayed treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Estimated Study Start Date : January 2017
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2018

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
Delayed treatment
albendazole at day 7, azithromycin at day 7
Drug: Delayed treatment

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03032042

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The Carter Center Ethiopia
Addis Ababa, Ethiopia
Sponsors and Collaborators
Francis I. Proctor Foundation
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Principal Investigator: Jeremy Keenan, MD, MPH F.I. Proctor Foundation, University of California San Francisco
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Responsible Party: Jeremy Keenan, Associate Professor, Francis I. Proctor Foundation Identifier: NCT03032042    
Other Study ID Numbers: 17-0101
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Keywords provided by Jeremy Keenan, Francis I. Proctor Foundation:
intestinal microbiome
soil-transmitted helminths
mass drug administration
Additional relevant MeSH terms:
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Parasitic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents