The Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in Vietnamese School Children
|
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. |
| 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Withdrawn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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
| 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. |
- 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.
- 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 ]
- 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 ]
- 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 ]
- Changes in blood cytokine (Th1, Th2, TH17, and Treg) levels by bead-based immunoassays [ Time Frame: Baseline, 6, and 12 months of study ]
- Antibody isotype response to helminth and diarrheal antigens by ELISA [ Time Frame: Baseline, 6, and 12 months ]
- Mean z-scores (height-for-age, weight-for-age, weight-for-height) [ Time Frame: Baseline and 12 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| Vietnam | |
| Cu Chi, Viet Nam | |
| Ho Chi Minh city, Vietnam, 700000 | |
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
|
Albendazole Ancylostoma duodenale Ascariasis lumbricoides Coinfection Diarrhea |
Helminths Necator americanus Microbiota Trichuris trichiura |
|
Helminthiasis Diarrhea Signs and Symptoms, Digestive Parasitic Diseases Infections 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 |