Deworming Against Tuberculosis

August 28, 2013 updated by: Thomas Schon, Linkoeping University

The Impact of Deworming on Host Immunity and Clinical Outcome in Patients With Pulmonary Tuberculosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Gondar
      • Gondar, Region 3, Ethiopia, Gondar, Ethiopia
        • University of Gondar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Albendazole
Albendazole 400mg per os once daily for three consecutive days
Drug: Albendazole
Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Other Names:
  • ALB
Placebo Comparator: Placebo
Placebo 400mg per os for three consecutive days
Drug: Placebo
Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in TB-score compared to baseline (Wejse et al 2007)
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sputum smear conversion
Time Frame: 3 months
3 months
Final outcome according to WHO
Time Frame: 6 months
6 months
Difference in ELIspot pattern (IL5, IFN-gamma and IL-10)
Time Frame: 3 months
3 months
Immunological response (IgE, Eosinophils, CD4-count)
Time Frame: 3 months
3 months
Chest X-ray improvement
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Armauer Hansen Research Institute, Ethiopia
University of Gondar

Investigators

  • Principal Investigator: Ebba Abate, MSc, University of Gondar and Linkoeping University
  • Principal Investigator: Ermias Diro, MD, University of Gondar
  • Study Director: Thomas Schoen, MD PhD, Linkoeping University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALBP
  • HLF-20060245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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