Deworming Against Tuberculosis

Condition(s) targeted: Tuberculosis

Intervention: Albendazole (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Linkoeping University

Official(s) and/or principal investigator(s):
Ebba Abate, MSc, Principal Investigator, Affiliation: University of Gondar and Linkoeping University
Endalkachew Melese, MD, Principal Investigator, Affiliation: University of Gondar
Thomas Schoen, MD PhD, Study Director, Affiliation: Linkoeping University, Sweden

Overall contact:
Ebba Abate, MSc, Phone: +251 911464024, Email: ebbaabate@yahoo.com

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

Official title: The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Smear Positive Tuberculosis

Study design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Change in TB-score compared to baseline (Wejse et al 2007)

Sputum smear conversion rate

Secondary outcome:

Change in Chest X-ray pattern

Final outcome according to WHO

Difference in ELIspot pattern (IL5, IFN-gamma and TGF-beta)

Immunological response (IgE, Eosinophils, CD4-count)

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Informed and written consent to take part in the study

- Newly diagnosed smear positive 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

Ebba Abate, MSc, Phone: +251 911464024, Email: ebbaabate@yahoo.com

University of Gondar, Gondar, Region 3, Ethiopia, Gondar, Ethiopia; Recruiting
Ebba Abate, MSc, Phone: +251911464024, Email: ebbaabate@yahoo.com
Endalkachew Melese, MD, Phone: +251911406681, Email: hildanaus@yahoo.com
Ebba Abate, MSc, Principal Investigator
Endalkachew Melese, MD, Principal Investigator
Shitaye Alemu, MD, Sub-Investigator
Assefa Getachew, MD, Sub-Investigator
Abraham Assefa, MD PhD, Sub-Investigator
Alermayeho Wurku, PhD, Sub-Investigator
Thomas Schoen, MD PhD, Sub-Investigator
Olle Stendahl, Professor, Sub-Investigator
Jonna Idh, MD, Sub-Investigator
Daniel Elias, PhD, Sub-Investigator

Related publications:

Borkow G, Bentwich Z. HIV and helminth co-infection: is deworming necessary? Parasite Immunol. 2006 Nov;28(11):605-12. Review.

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. Epub 2005 Aug 25.

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.

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.

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.

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-Guérin (BCG) vaccination. Clin Exp Immunol. 2001 Feb;123(2):219-25.

Starting date: March 2009
Ending date: March 2012
Last updated: June 5, 2009