The Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in Vietnamese School Children

December 14, 2016 updated by: Oxford University Clinical Research Unit, Vietnam

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in School Children in Southern Vietnam

Cheap and effective drugs called 'anthelmintics' are routinely administered to children in developing countries to eliminate infections by parasitic helminths. However, the effects of anthelmintic treatment on other pathogens (e.g., bacteria, viruses, protozoa) remain unknown. The aim of this study is to investigate the impact of anthelmintic treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam. Diarrheal disease remains a substantial cause of morbidity and mortality in children in Vietnam, and these children are typically co-infected with intestinal helminths. As helminths and diarrheal pathogens infect the same intestinal niche, anthelmintic treatments may alter host immune responses and the composition of the gut microbiota in ways that affect infection and disease risks caused by diarrheal pathogens.

This study will recruit 350 helminth-infected and 350 helminth-uninfected children aged 6-15 years. Recruited children will be randomized to receive either anthelmintic or placebo treatment once every three months and will be monitored for incidences of diarrheal disease for 12 months. At the 12-month time point, all children will receive anthelmintic treatment. Blood and stool samples will be collected throughout the study and used for evaluation of anemia and host immune responses, and for classification of gut microbes and parasite detection, respectively. The interventional study proposed here will provide an important first test of whether anthelmintic treatments have any indirect effects on infections caused by diarrheal pathogens.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, double-blind, placebo-controlled trial to evaluate the effects of 400 mg albendazole treatment against placebo on the incidence of diarrheal disease caused by viral and bacterial pathogens in school children in southern Vietnam. Children will be enrolled from three primary schools in Cu Chi district in Ho Chi Minh City, Vietnam. Children will be screened for infections by the four most common soil-transmitted helminths, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, and Ancylostoma duodenale. Infected and uninfected individuals will be recruited into the study and randomized to either receive albendazole treatment once every three months for 12 months, or to placebo once every three months for 9 months, after which albendazole treatment will be given at month 12, in accordance with the current deworming schedule in Cu Chi district. A questionnaire regarding the participant's demographics, his/her daily habits, and potential sources of infection will be administered at baseline. Weekly active and passive surveillance of diarrheal cases will be conducted throughout the study, and a health questionnaire will be administered during all cases of diarrhea and at the end of the study.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh city, Vietnam, 700000
        • Cu Chi, Viet Nam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 6-15 years of age
  • Written informed consent from a parent or guardian
  • Written assent from children >10 years of age

Exclusion Criteria:

  • Subjects who do not fulfill any component of the inclusion criteria
  • Subjects that are both hookworm-positive and anemic, as defined by the WHO guidelines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Albendazole
Albendazole will be administered as a single 400mg chewable tablet at 0, 3, 6, 9, and 12 months.
Drug: Albendazole
A single 400mg dose of Albendazole administered at 0, 3, 6, 9, and 12 months.
Placebo Comparator: Placebo
Matching Placebo will be administered as a single chewable tablet at 0, 3, 6, and 9 months. At month 12, all participants will receive a single 400mg Albendazole tablet.
Drug: Placebo
Matching placebo tablet administered at 0, 3, 6, and 9 months. At month 12, all participants will receive a single dose of 400mg Albendazole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of diarrheal disease assessed by 12 months of weekly active and passive case surveillance
Time Frame: 12 months
Incidence of diarrhea will be defined according to WHO guidelines as three or more loose stools in a 24-hour period or at least one bloody/mucoid stool. To be considered a new episode of diarrhea, at least three intervening days of normal stools without other gastrointestinal symptoms need to have passed between diarrhea occurrences.
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence and intensity of soil-transmitted helminth infections by real-time PCR and microscopy
Time Frame: Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases
Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases
Prevalence and intensity of enteric viruses and bacteria that cause diarrhea assessed by real-time PCR and the Luminex xTAG Gastrointestinal Pathogen Panel
Time Frame: Time Frame: Baseline, 3, 6, 9, and 12 months, and during and two weeks after diarrhea cases
Time Frame: Baseline, 3, 6, 9, and 12 months, and during and two weeks after diarrhea cases
Changes in fecal microbiota composition by Illumina sequencing
Time Frame: Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases
Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases
Changes in blood cytokine (Th1, Th2, TH17, and Treg) levels by bead-based immunoassays
Time Frame: Baseline, 6, and 12 months of study
Baseline, 6, and 12 months of study
Antibody isotype response to helminth and diarrheal antigens by ELISA
Time Frame: Baseline, 6, and 12 months
Baseline, 6, and 12 months
Mean z-scores (height-for-age, weight-for-age, weight-for-height)
Time Frame: Baseline and 12 months
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Princeton University
Ho Chi Minh Preventive Medicine Centre, Vietnam
Cu Chi Health Department

Investigators

  • Principal Investigator: Stephen Baker, PhD, Oxford University Clinical Research Unit
  • Principal Investigator: Nghia Ho Dang Trung, PhD, MD, Pham Ngoc Thach University of Medicine
  • Principal Investigator: Andrea Graham, PhD, Princeton University, USA
  • Study Director: Jacqueline Leung, MA, Princeton University, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16EN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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