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

Trials

Volumn 16, Issue 1, 2015, Pages

  Nampijja, Margaret ^a   Webb, Emily L ^b   Kaweesa, James ^c   Kizindo, Robert ^a   Namutebi, Milly ^a   Nakazibwe, Esther ^d   Oduru, Gloria ^a   Kabuubi, Prossy ^a   Kabagenyi, Joyce ^a   Kizito, Dennison ^a   Muhangi, Lawrence ^a   Akello, Mirriam ^a   Verweij, Jaco J ^e   Nerima, Barbara ^f   Tukahebwa, Edridah ^c   Elliott, Alison M ^a,b   Sanya, Richard ^g   Mirembe, Beatrice ^g   Okello, Justin ^g   Levin, Jonathan ^g   Zziwa, Christopher ^g   Tumusiime, Josephine ^g   Sewankambo, Moses ^g   Nsubuga, Denis ^g   Niwagaba, Emmanuel ^g   Kabwami, Grace ^g   Abayo, Elson ^g   Nkurunungi, Gyaviira ^g   Muwonge, Fred ^g   Abiriga, David ^g   Nannozi, Victoria ^g   more..

^a MEDICAL RESEARCH COUNCIL   (United Kingdom)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c MINISTRY OF HEALTH   (Uganda)

^d Entebbe Hospital   (Uganda)

^e CPRLab   (Netherlands)

^f UGANDA VIRUS RESEARCH INSTITUTE   (Uganda)

^g NONE

Author keywords

Allergy; Anthelminthic treatment; Atopy; Cluster randomised trial; Helminths; Wheeze

Indexed keywords

ALBENDAZOLE; HEMOGLOBIN; IMMUNOGLOBULIN E; PRAZIQUANTEL; ANTHELMINTIC AGENT; BIOLOGICAL MARKER;

ADOLESCENT; ADULT; ALLERGY; ARTICLE; ATOPY; CHILD; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; DERMATITIS; HEALTH SURVEY; HELMINTHIASIS; HEPATOSPLENOMEGALY; HUMAN; INFANT; INTERVENTION STUDY; LAKE VICTORIA ISLAND INTERVENTION STUDY ON WORMS AND ALLERGY RELATED DISEASE; MAJOR CLINICAL STUDY; MIDDLE AGED; OUTCOME ASSESSMENT; PRESCHOOL CHILD; PREVALENCE; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SINGLE DRUG DOSE; TREATMENT RESPONSE; UGANDA; WHEEZING; YOUNG ADULT; ABNORMAL RESPIRATORY SOUND; ANIMAL; BLOOD; CLINICAL PROTOCOL; CLINICAL TRIAL; DERMATITIS, ATOPIC; DRUG ADMINISTRATION; DRUG EFFECTS; HOST PARASITE INTERACTION; IMMUNOLOGY; INTRACUTANEOUS TEST; METABOLISM; METHODOLOGY; MULTICENTER STUDY; PARASITOLOGY; PATHOGENICITY; RESPIRATORY HYPERSENSITIVITY; SCHISTOSOMA MANSONI; SCHISTOSOMIASIS MANSONI; STRONGYLOIDES STERCORALIS; STRONGYLOIDIASIS; TIME FACTOR; TREATMENT OUTCOME; TRICHURIASIS; TRICHURIS;

ALBENDAZOLE; ANIMALS; ANTHELMINTICS; BIOMARKERS; CLINICAL PROTOCOLS; DERMATITIS, ATOPIC; DRUG ADMINISTRATION SCHEDULE; HEMOGLOBINS; HOST-PARASITE INTERACTIONS; HUMANS; IMMUNOGLOBULIN E; INTRADERMAL TESTS; PRAZIQUANTEL; RESEARCH DESIGN; RESPIRATORY HYPERSENSITIVITY; RESPIRATORY SOUNDS; SCHISTOSOMA MANSONI; SCHISTOSOMIASIS MANSONI; STRONGYLOIDES STERCORALIS; STRONGYLOIDIASIS; TIME FACTORS; TREATMENT OUTCOME; TRICHURIASIS; TRICHURIS; UGANDA;

EID: 84928567190     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0702-5     Document Type: Article

References (53)

1. Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, et al. Economic burden of asthma: a systematic review. BMC Pulm Med. 2009;9:24.
2. Carroll CL, Balkrishnan R, Feldman SR, Fleischer Jr AB, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005;22(3):192-9.
3. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004;59(5):469-78.
4. Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007;28(1):3-9.
5. Anandan C, Nurmatov U, van Schayck OC, Sheikh A. Is the prevalence of asthma declining? Systematic review of epidemiological studies. Allergy. 2010;65(2):152-67.
6. Anderson HR, Gupta R, Strachan DP, Limb ES. 50 years of asthma: UK trends from 1955 to 2004. Thorax. 2007;62(1):85-90.
7. Cooper PJ, Rodrigues LC, Cruz AA, Barreto ML. Asthma in Latin America: a public heath challenge and research opportunity. Allergy. 2009;64(1):5-17.
8. Souza-Machado C, Souza-Machado A, Franco R, Ponte EV, Barreto ML, Rodrigues LC, et al. Rapid reduction in hospitalisations after an intervention to manage severe asthma. Eur Respir J. 2010;35(3):515-21.
9. The Global Asthma Report 2011. International Union Against Tuberculosis and Lung Disease, Paris, France.
10. Hotez PJ, Brindley PJ, Bethony JM, King CH, Pearce EJ, Jacobson J. Helminth infections: the great neglected tropical diseases. J Clin Invest. 2008;118(4):1311-21.
11. King CH, Dangerfield-Cha M. The unacknowledged impact of chronic schistosomiasis. Chronic Illn. 2008;4(1):65-79.
12. Kabatereine NB, Brooker S, Koukounari A, Kazibwe F, Tukahebwa EM, Fleming FM, et al. Impact of a national helminth control programme on infection and morbidity in Ugandan schoolchildren. Bull World Health Organ. 2007;85(2):91-9.
13. Hewitson JP, Grainger JR, Maizels RM. Helminth immunoregulation: the role of parasite secreted proteins in modulating host immunity. Mol Biochem Parasitol. 2009;167(1):1-11.
14. van Riet E, Hartgers FC, Yazdanbakhsh M. Chronic helminth infections induce immunomodulation: consequences and mechanisms. Immunobiology. 2007;212(6):475-90.
15. Bentwich Z, Kalinkovich A, Weisman Z, Borkow G, Beyers N, Beyers AD. Can eradication of helminthic infections change the face of AIDS and tuberculosis? Immunol Today. 1999;20(11):485-7.
16. Fitzsimmons CM, Dunne DW. Survival of the fittest: allergology or parasitology? Trends Parasitol. 2009;25(10):447-51.
17. Smits HH, Everts B, Hartgers FC, Yazdanbakhsh M. Chronic helminth infections protect against allergic diseases by active regulatory processes. Curr Allergy Asthma Rep. 2010;10(1):3-12.
18. Wammes LJ, Mpairwe H, Elliott AM, Yazdanbakhsh M. Global worming or deworming? A review of contrasting scientific directions. Lancet Infect Dis. 2014;14(11):1150-62.
19. Kouriba B, Chevillard C, Bream JH, Argiro L, Dessein H, Arnaud V, et al. Analysis of the 5q31-q33 locus shows an association between IL13-1055C/T IL-13-591A/G polymorphisms and Schistosoma haematobium infections. J Immunol. 2005;174(10):6274-81.
20. Moller M, Gravenor MB, Roberts SE, Sun D, Gao P, Hopkin JM. Genetic haplotypes of Th-2 immune signalling link allergy to enhanced protection to parasitic worms. Hum Mol Genet. 2007;16(15):1828-36.
21. Lynch NR, Hagel I, Perez M, Di Prisco MC, Lopez R, Alvarez N. Effect of anthelmintic treatment on the allergic reactivity of children in a tropical slum. J Allergy Clin Immunol. 1993;92(3):404-11.
22. van den Biggelaar AH, Rodrigues LC, van Ree R, van der Zee JS, Hoeksma-Kruize YC, Souverijn JH, et al. Long-term treatment of intestinal helminths increases mite skin-test reactivity in Gabonese schoolchildren. J Infect Dis. 2004;189(5):892-900.
23. Flohr C, Tuyen LN, Quinnell RJ, Lewis S, Minh TT, Campbell J, et al. Reduced helminth burden increases allergen skin sensitization but not clinical allergy: a randomized, double-blind, placebo-controlled trial in Vietnam. Clin Exp Allergy. 2010;40(1):131-42.
24. Cooper PJ, Chico ME, Vaca MG, Moncayo AL, Bland JM, Mafla E, et al. Effect of albendazole treatments on the prevalence of atopy in children living in communities endemic for geohelminth parasites: a cluster-randomised trial. Lancet. 2006;367(9522):1598-603.
25. Flohr C, Quinnell RJ, Britton J. Do helminth parasites protect against atopy and allergic disease? Clin Exp Allergy. 2009;39(1):20-32.
26. World Health Organization. Prevention and control of schistosomiasis and soil-transmitted helminthiasis: report of a WHO expert committee. Geneva: World Health Organization; 2002. Report No.: 912.
27. Taylor-Robinson D, Jones A, Garner P. Does deworming improve growth and school performance in children? PLoS Negl Trop Dis. 2009;3(1):e358.
28. Taylor-Robinson DC, Jones AP, Garner P. Deworming drugs for treating soil-transmitted intestinal worms in children: effects on growth and school performance. Cochrane Database Syst Rev. 2007;4:CD000371.
29. Montresor A, Engels D, Chitsulo L, Bundy DA, Brooker S, Savioli L. Development and validation of a 'tablet pole' for the administration of praziquantel in sub-Saharan Africa. Trans R Soc Trop Med Hyg. 2001;95(5):542-4.
30. Sousa-Figueiredo JC, Day M, Betson M, Kabatereine NB, Stothard JR. An inclusive dose pole for treatment of schistosomiasis in infants and preschool children with praziquantel. Trans R Soc Trop Med Hyg. 2010;104(11):740-2.
31. Stothard JR, Sousa-Figueiredo JC, Betson M, Green HK, Seto EY, Garba A, et al. Closing the praziquantel treatment gap: new steps in epidemiological monitoring and control of schistosomiasis in African infants and preschool-aged children. Parasitology. 2011;138(12):1593-606.
32. Speich B, Ame SM, Ali SM, Alles R, Hattendorf J, Utzinger J, et al. Efficacy and safety of nitazoxanide, albendazole, and nitazoxanide-albendazole against Trichuris trichiura infection: a randomized controlled trial. PLoS Negl Trop Dis. 2012;6(6):e1685.
33. Steinmann P, Utzinger J, Du ZW, Jiang JY, Chen JX, Hattendorf J, et al. Efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminths and Taenia spp.: a randomized controlled trial. PLoS One. 2011;6(9):e25003.
34. World Health Organization. Report of the WHO informal consultation on hookworm infection and anaemia in girls and women. Geneva: WHO; 1994. Report No.: WHO/CTD/SIP/96.1.
35. Mpairwe H, Webb EL, Muhangi L, Ndibazza J, Akishule D, Nampijja M, et al. Anthelminthic treatment during pregnancy is associated with increased risk of infantile eczema: randomised-controlled trial results. Pediatr Allergy Immunol. 2011;22(3):305-12.
36. Ndibazza J, Muhangi L, Akishule D, Kiggundu M, Ameke C, Oweka J, et al. Effects of deworming during pregnancy on maternal and perinatal outcomes in Entebbe, Uganda: a randomized controlled trial. Clin Infect Dis. 2010;50(4):531-40.
37. Ellwood P, Asher M, Beasley R, Clayton T, Stewart A, on behalf of the ISAAC Steering Committee and the ISAAC Phase Three Study Group, et al. ISAAC International Data Centre. New Zealand: Auckland; 2000.
38. Brenninkmeijer EE, Schram ME, Leeflang MM, Bos JD, Spuls PI. Diagnostic criteria for atopic dermatitis: a systematic review. Br J Dermatol. 2008;158(4):754-65.
39. Williams HC. So how do I define Atopic Eczema? A practical manual for researchers wishing to define atopic eczema. Nottingham: Dermato-Epidemiology Unit, Queens Medical Centre.
40. Cox L, Williams B, Sicherer S, Oppenheimer J, Sher L, Hamilton R, et al. Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force. Ann Allergy Asthma Immunol. 2008;101(6):580-92.
41. Katz N, Chaves A, Pellegrino J. A simple device for quantitative stool thick-smear technique in Schistosomiasis mansoni. Rev Inst Med Trop Sao Paulo. 1972;14(6):397-400.
42. Verweij JJ, Brienen EA, Ziem J, Yelifari L, Polderman AM, Van Lieshout L. Simultaneous detection and quantification of Ancylostoma duodenale, Necator americanus, and Oesophagostomum bifurcum in fecal samples using multiplex real-time PCR. Am J Trop Med Hyg. 2007;77(4):685-90.
43. Verweij JJ, Canales M, Polman K, Ziem J, Brienen EA, Polderman AM, et al. Molecular diagnosis of Strongyloides stercoralis in faecal samples using real-time PCR. Trans R Soc Trop Med Hyg. 2009;103(4):342-6.
44. Melrose WD, Turner PF, Pisters P, Turner B. An improved Knott's concentration test for the detection of microfilariae. Trans R Soc Trop Med Hyg. 2000;94(2):176.
45. Webb EL, Mawa PA, Ndibazza J, Kizito D, Namatovu A, Kyosiimire-Lugemwa J, et al. Effect of single-dose anthelmintic treatment during pregnancy on an infan''s response to immunisation and on susceptibility to infectious diseases in infancy: a randomised, double-blind, placebo-controlled trial. Lancet. 2011;377(9759):52-62.
46. Elliott AM, Mawa PA, Webb EL, Nampijja M, Lyadda N, Bukusuba J, et al. Effects of maternal and infant co-infections, and of maternal immunisation, on the infant response to BCG and tetanus immunisation. Vaccine. 2010;29(2):247-55.
47. Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999;28(2):319-26.
48. Hayes R, Moulton LH. Cluster randomised trials. London, UK: Chapman and Hall/CRC press; 2009.
49. Joint United Nations Programme on HIV/AIDS. Global report: UNAIDS report on the global AIDS epidemic. Geneva: UNAIDS; 2013. Report No.: WC 503.6.
50. World Health Organization. Monitoring helminth control programmes. Guidelines for monitoring the impact of control programmes aimed at reducing morbidity caused by soil-transmitted helminths and schistosomes, with particular reference to school-age children. Geneva: World Health Organisation; 1999.
51. Utzinger J, Booth M, N'Goran EK, Muller I, Tanner M, Lengeler C. Relative contribution of day-to-day and intra-specimen variation in faecal egg counts of Schistosoma mansoni before and after treatment with praziquantel. Parasitology. 2001;122(Pt 5):537-44.
52. Pearce N, Beasley R, Pekkanen J. Role of bronchial responsiveness testing in asthma prevalence surveys. Thorax. 2000;55(5):352-4.
53. Pekkanen J, Pearce N. Defining asthma in epidemiological studies. Eur Respir J. 1999;14(4):951-7.