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The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial

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 re...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413531/
https://www.ncbi.nlm.nih.gov/pubmed/25902705
http://dx.doi.org/10.1186/s13063-015-0702-5
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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
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
author_sort Nampijja, Margaret
collection PubMed
description 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 of reported wheeze and positive skin prick test to any allergen was 5% and 20%, respectively. Respectively, 77% and 87% of participants had Dermatophagoides- and German cockroach-specific IgE above 0.35 kUA/L. These characteristics suggest that the LaVIISWA study will provide an excellent framework for investigating beneficial and detrimental effects of worms and their treatment, and the mechanisms of such effects. TRIAL REGISTRATION: This trial was registered with Current Controlled Trials (identifier: ISRCTN47196031) on 7 September 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0702-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-44135312015-04-30 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 Trials Study Protocol 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 of reported wheeze and positive skin prick test to any allergen was 5% and 20%, respectively. Respectively, 77% and 87% of participants had Dermatophagoides- and German cockroach-specific IgE above 0.35 kUA/L. These characteristics suggest that the LaVIISWA study will provide an excellent framework for investigating beneficial and detrimental effects of worms and their treatment, and the mechanisms of such effects. TRIAL REGISTRATION: This trial was registered with Current Controlled Trials (identifier: ISRCTN47196031) on 7 September 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0702-5) contains supplementary material, which is available to authorized users. BioMed Central 2015-04-23 /pmc/articles/PMC4413531/ /pubmed/25902705 http://dx.doi.org/10.1186/s13063-015-0702-5 Text en © Nampijja et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
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
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial
title 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_short 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4413531/
https://www.ncbi.nlm.nih.gov/pubmed/25902705
http://dx.doi.org/10.1186/s13063-015-0702-5
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