Clinical trial NCT00857116: Deworming Against Tuberculosis
Official title: The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Deworming
Tuberculosis
TB-score
Albendazole
Helminths
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University of Gondar
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2009-03-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate whether treatment against intestinal helminths in patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical outcome by enhancing host immunity.

Detailed description: Mycobacterium tuberculosis causing tuberculosis (TB) is a major global public health problem. Because of increasing multi drug resistance and the long treatment period of at least six months, new therapeutic options are urgently needed. In countries like Ethiopia where TB is endemic, chronic worm infection is also highly prevalent. Recent data support that helminth infection might limit the host response against TB by inhibition of the TH1-response that is crucial in controlling the disease. In this study we want to test the hypothesis that Albendazole treatment of patients coinfected with helminths and TB could improve clinical outcome in addition to chemotherapy against TB. Additionally we will investigate the immunological interactions between TB and chronic helminths infection.

Eligibility criteria: Inclusion Criteria:

* Informed and written consent to take part in the study
* Newly diagnosed pulmonary TB patients according to the WHO definitions of active tuberculosis who have a positive stool sample for helminths other than Schistosoma spp.

Exclusion Criteria:

* Pregnancy
* Corticosteroid or antibiotic treatment
* Symptomatic (diarrhoea) infection caused by worm infection
* Chronic diseases or acute infectious diseases other than TB or HIV
* Stool sample positive for Schistosoma spp

Primary outcomes:
measure: Change in TB-score compared to baseline (Wejse et al 2007)
timeFrame: 2 months
Secondary outcomes:
measure: Sputum smear conversion
timeFrame: 3 months
measure: Final outcome according to WHO
timeFrame: 6 months
measure: Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)
timeFrame: 3 months
measure: Immunological response (IgE, Eosinophils, CD4-count)
timeFrame: 3 months
measure: Chest X-ray improvement
timeFrame: 3 months
Other outcomes:
Locations:
city: Gondar, Region 3, Ethiopia
country: Ethiopia
facility: University of Gondar
state: Gondar
Study officials:
affiliation: University of Gondar and Linkoeping University
name: Ebba Abate, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Gondar
name: Ermias Diro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University, Sweden
name: Thomas Schoen, MD PhD
role: STUDY_DIRECTOR
References:
citation: Borkow G, Bentwich Z. HIV and helminth co-infection: is deworming necessary? Parasite Immunol. 2006 Nov;28(11):605-12. doi: 10.1111/j.1365-3024.2006.00918.x.
citation: Modjarrad K, Zulu I, Redden DT, Njobvu L, Lane HC, Bentwich Z, Vermund SH. Treatment of intestinal helminths does not reduce plasma concentrations of HIV-1 RNA in coinfected Zambian adults. J Infect Dis. 2005 Oct 1;192(7):1277-83. doi: 10.1086/444543. Epub 2005 Aug 25.
citation: Kassu A, Mengistu G, Ayele B, Diro E, Mekonnen F, Ketema D, Moges F, Mesfin T, Getachew A, Ergicho B, Elias D, Wondmikun Y, Aseffa A, Ota F. HIV and intestinal parasites in adult TB patients in a teaching hospital in Northwest Ethiopia. Trop Doct. 2007 Oct;37(4):222-4. doi: 10.1258/004947507782333026.
citation: Elias D, Akuffo H, Thors C, Pawlowski A, Britton S. Low dose chronic Schistosoma mansoni infection increases susceptibility to Mycobacterium bovis BCG infection in mice. Clin Exp Immunol. 2005 Mar;139(3):398-404. doi: 10.1111/j.1365-2249.2004.02719.x.
citation: Elias D, Mengistu G, Akuffo H, Britton S. Are intestinal helminths risk factors for developing active tuberculosis? Trop Med Int Health. 2006 Apr;11(4):551-8. doi: 10.1111/j.1365-3156.2006.01578.x.
citation: Elias D, Wolday D, Akuffo H, Petros B, Bronner U, Britton S. Effect of deworming on human T cell responses to mycobacterial antigens in helminth-exposed individuals before and after bacille Calmette-Guerin (BCG) vaccination. Clin Exp Immunol. 2001 Feb;123(2):219-25. doi: 10.1046/j.1365-2249.2001.01446.x.
citation: Abate E, Elias D, Getachew A, Alemu S, Diro E, Britton S, Aseffa A, Stendahl O, Schon T. Effects of albendazole on the clinical outcome and immunological responses in helminth co-infected tuberculosis patients: a double blind randomised clinical trial. Int J Parasitol. 2015 Feb;45(2-3):133-40. doi: 10.1016/j.ijpara.2014.09.006. Epub 2014 Dec 5.