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Trial record 1 of 1 for:    NCT02597556
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The Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in Vietnamese School Children

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ClinicalTrials.gov Identifier: NCT02597556
Recruitment Status : Withdrawn (The prevalence of worm infections in the site is significantly lower than expected)
First Posted : November 5, 2015
Last Update Posted : December 15, 2016
Sponsor:
Collaborators:
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Ho Chi Minh Preventive Medicine Centre, Vietnam
Princeton University
Cu Chi Health Department
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Intestinal Helminthiasis Diarrhea Drug: Albendazole Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Albendazole

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Changes in blood cytokine (Th1, Th2, TH17, and Treg) levels by bead-based immunoassays [ Time Frame: Baseline, 6, and 12 months of study ]
  5. Antibody isotype response to helminth and diarrheal antigens by ELISA [ Time Frame: Baseline, 6, and 12 months ]
  6. Mean z-scores (height-for-age, weight-for-age, weight-for-height) [ Time Frame: Baseline and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02597556


Locations
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Vietnam
Cu Chi, Viet Nam
Ho Chi Minh city, Vietnam, 700000
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Ho Chi Minh Preventive Medicine Centre, Vietnam
Princeton University
Cu Chi Health Department
Investigators
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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
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT02597556    
Other Study ID Numbers: 16EN
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Albendazole
Ancylostoma duodenale
Ascariasis lumbricoides
Coinfection
Diarrhea
Helminths
Necator americanus
Microbiota
Trichuris trichiura
Additional relevant MeSH terms:
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Helminthiasis
Diarrhea
Signs and Symptoms, Digestive
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents