Diarrhea Clinical Trial
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
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years to 15 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Vietnam | Cu Chi, Viet Nam | Ho Chi Minh city |
Lead Sponsor | Collaborator |
---|---|
Oxford University Clinical Research Unit, Vietnam | Cu Chi Health Department, Ho Chi Minh Preventive Medicine Centre, Vietnam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Princeton University |
Vietnam,
Blackwell AD, Martin M, Kaplan H, Gurven M. Antagonism between two intestinal parasites in humans: the importance of co-infection for infection risk and recovery dynamics. Proc Biol Sci. 2013 Aug 28;280(1769):20131671. doi: 10.1098/rspb.2013.1671. — View Citation
Ezenwa VO, Jolles AE. Epidemiology. Opposite effects of anthelmintic treatment on microbial infection at individual versus population scales. Science. 2015 Jan 9;347(6218):175-7. doi: 10.1126/science.1261714. — View Citation
Ferrari N, Cattadori IM, Rizzoli A, Hudson PJ. Heligmosomoides polygyrus reduces infestation of Ixodes ricinus in free-living yellow-necked mice, Apodemus flavicollis. Parasitology. 2009 Mar;136(3):305-16. doi: 10.1017/S0031182008005404. — View Citation
Knowles SC, Fenton A, Petchey OL, Jones TR, Barber R, Pedersen AB. Stability of within-host-parasite communities in a wild mammal system. Proc Biol Sci. 2013 May 15;280(1762):20130598. doi: 10.1098/rspb.2013.0598. — View Citation
Nacher M. Worms and malaria: resisting the temptation to generalize. Trends Parasitol. 2006 Aug;22(8):350-1; author reply 351-2. — View Citation
Pedersen AB, Antonovics J. Anthelmintic treatment alters the parasite community in a wild mouse host. Biol Lett. 2013 May 8;9(4):20130205. doi: 10.1098/rsbl.2013.0205. — View Citation
Rousham EK. An increase in Giardia duodenalis infection among children receiving periodic Anthelmintic treatment in Bangladesh. J Trop Pediatr. 1994 Dec;40(6):329-33. — View Citation
Taylor-Robinson DC, Maayan N, Soares-Weiser K, Donegan S, Garner P. Deworming drugs for soil-transmitted intestinal worms in children: effects on nutritional indicators, haemoglobin, and school performance. Cochrane Database Syst Rev. 2015 Jul 23;(7):CD000371. doi: 10.1002/14651858.CD000371.pub6. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of diarrheal disease assessed by 12 months of weekly active and passive case surveillance | 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 | No |
Secondary | Prevalence and intensity of soil-transmitted helminth infections by real-time PCR and microscopy | Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases | No | |
Secondary | 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: Baseline, 3, 6, 9, and 12 months, and during and two weeks after diarrhea cases | No | |
Secondary | Changes in fecal microbiota composition by Illumina sequencing | Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases | No | |
Secondary | Changes in blood cytokine (Th1, Th2, TH17, and Treg) levels by bead-based immunoassays | Baseline, 6, and 12 months of study | No | |
Secondary | Antibody isotype response to helminth and diarrheal antigens by ELISA | Baseline, 6, and 12 months | No | |
Secondary | Mean z-scores (height-for-age, weight-for-age, weight-for-height) | Baseline and 12 months | No |
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