The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial
Abstract Background The Hygiene Hypothesis proposes that infection exposure protects against inflammatory conditions. Helminths possess allergen-like molecules and may specifically modulate allergy-related immunological pathways to inhibit responses which protect against them. Mass drug administrati...
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ftbiomed:oai:biomedcentral.com:s13063-015-0702-5 2023-05-15T18:42:48+02:00 The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial Nampijja, Margaret Webb, Emily L Kaweesa, James Kizindo, Robert Namutebi, Milly Nakazibwe, Esther Oduru, Gloria Kabuubi, Prossy Kabagenyi, Joyce Kizito, Dennison Muhangi, Lawrence Akello, Mirriam Verweij, Jaco J Nerima, Barbara Tukahebwa, Edridah Elliott, Alison M for the LaVIISWA trial team 2015-04-23 http://www.trialsjournal.com/content/16/1/187 en eng BioMed Central Ltd. http://www.trialsjournal.com/content/16/1/187 Copyright 2015 Nampijja et al.; licensee BioMed Central. Helminths Anthelminthic treatment Allergy Atopy Wheeze Cluster-randomised trial Study protocol 2015 ftbiomed 2015-05-02T23:56:20Z Abstract Background The Hygiene Hypothesis proposes that infection exposure protects against inflammatory conditions. Helminths possess allergen-like molecules and may specifically modulate allergy-related immunological pathways to inhibit responses which protect against them. Mass drug administration is recommended for helminth-endemic communities to control helminth-induced pathology, but may also result in increased rates of inflammation-mediated diseases in resource-poor settings. Immunological studies integrated with implementation of helminth control measures may elucidate how helminth elimination contributes to ongoing epidemics of inflammatory diseases. We present the design of the Lake Victoria Island Intervention Study on Worms and Allergy-related diseases (LaVIISWA), a cluster-randomised trial evaluating the risks and benefits of intensive versus standard anthelminthic treatment for allergy-related diseases and other health outcomes. Methods/Design The setting is comprised of island fishing communities in Mukono district, Uganda. Twenty-six communities have been randomised in a 1:1 ratio to receive standard or intensive anthelminthic intervention for a three-year period. Baseline characteristics were collected immediately prior to intervention rollout, commenced in February 2013. Primary outcomes are reported wheeze in the past 12 months and atopy (skin prick test response and allergen-specific immunoglobulin (asIg) E concentration). Secondary outcomes are visible flexural dermatitis, helminth infections, haemoglobin, growth parameters, hepatosplenomegaly, and responses to vaccine antigens. The trial provides a platform for in-depth analysis of clinical and immunological consequences of the contrasting interventions. Discussion The baseline survey has been completed successfully in a challenging environment. Baseline characteristics were balanced between trial arms. Prevalence of Schistosoma mansoni , hookworm, Strongyloides stercoralis and Trichuris trichiura was 52%, 23%, 13%, and 12%, respectively; 31% of Schistosoma mansoni infections were heavy (>400 eggs/gram). The prevalence . Other/Unknown Material Victoria Island BioMed Central |
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Open Polar |
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BioMed Central |
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ftbiomed |
language |
English |
topic |
Helminths Anthelminthic treatment Allergy Atopy Wheeze Cluster-randomised trial |
spellingShingle |
Helminths Anthelminthic treatment Allergy Atopy Wheeze Cluster-randomised trial Nampijja, Margaret Webb, Emily L Kaweesa, James Kizindo, Robert Namutebi, Milly Nakazibwe, Esther Oduru, Gloria Kabuubi, Prossy Kabagenyi, Joyce Kizito, Dennison Muhangi, Lawrence Akello, Mirriam Verweij, Jaco J Nerima, Barbara Tukahebwa, Edridah Elliott, Alison M for the LaVIISWA trial team The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial |
topic_facet |
Helminths Anthelminthic treatment Allergy Atopy Wheeze Cluster-randomised trial |
description |
Abstract Background The Hygiene Hypothesis proposes that infection exposure protects against inflammatory conditions. Helminths possess allergen-like molecules and may specifically modulate allergy-related immunological pathways to inhibit responses which protect against them. Mass drug administration is recommended for helminth-endemic communities to control helminth-induced pathology, but may also result in increased rates of inflammation-mediated diseases in resource-poor settings. Immunological studies integrated with implementation of helminth control measures may elucidate how helminth elimination contributes to ongoing epidemics of inflammatory diseases. We present the design of the Lake Victoria Island Intervention Study on Worms and Allergy-related diseases (LaVIISWA), a cluster-randomised trial evaluating the risks and benefits of intensive versus standard anthelminthic treatment for allergy-related diseases and other health outcomes. Methods/Design The setting is comprised of island fishing communities in Mukono district, Uganda. Twenty-six communities have been randomised in a 1:1 ratio to receive standard or intensive anthelminthic intervention for a three-year period. Baseline characteristics were collected immediately prior to intervention rollout, commenced in February 2013. Primary outcomes are reported wheeze in the past 12 months and atopy (skin prick test response and allergen-specific immunoglobulin (asIg) E concentration). Secondary outcomes are visible flexural dermatitis, helminth infections, haemoglobin, growth parameters, hepatosplenomegaly, and responses to vaccine antigens. The trial provides a platform for in-depth analysis of clinical and immunological consequences of the contrasting interventions. Discussion The baseline survey has been completed successfully in a challenging environment. Baseline characteristics were balanced between trial arms. Prevalence of Schistosoma mansoni , hookworm, Strongyloides stercoralis and Trichuris trichiura was 52%, 23%, 13%, and 12%, respectively; 31% of Schistosoma mansoni infections were heavy (>400 eggs/gram). The prevalence . |
format |
Other/Unknown Material |
author |
Nampijja, Margaret Webb, Emily L Kaweesa, James Kizindo, Robert Namutebi, Milly Nakazibwe, Esther Oduru, Gloria Kabuubi, Prossy Kabagenyi, Joyce Kizito, Dennison Muhangi, Lawrence Akello, Mirriam Verweij, Jaco J Nerima, Barbara Tukahebwa, Edridah Elliott, Alison M for the LaVIISWA trial team |
author_facet |
Nampijja, Margaret Webb, Emily L Kaweesa, James Kizindo, Robert Namutebi, Milly Nakazibwe, Esther Oduru, Gloria Kabuubi, Prossy Kabagenyi, Joyce Kizito, Dennison Muhangi, Lawrence Akello, Mirriam Verweij, Jaco J Nerima, Barbara Tukahebwa, Edridah Elliott, Alison M for the LaVIISWA trial team |
author_sort |
Nampijja, Margaret |
title |
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial |
title_short |
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial |
title_full |
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial |
title_fullStr |
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial |
title_full_unstemmed |
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial |
title_sort |
lake victoria island intervention study on worms and allergy-related diseases (laviiswa): study protocol for a randomised controlled trial |
publisher |
BioMed Central Ltd. |
publishDate |
2015 |
url |
http://www.trialsjournal.com/content/16/1/187 |
genre |
Victoria Island |
genre_facet |
Victoria Island |
op_relation |
http://www.trialsjournal.com/content/16/1/187 |
op_rights |
Copyright 2015 Nampijja et al.; licensee BioMed Central. |
_version_ |
1766232575986106368 |