NCT01301144

Oral Urea Breath Testing for Diagnosis and Treatment Response in Pulmonary Tuberculosis

Completed Last updated 5 April 2018

What this trial tests

trial in Tuberculosis in 113 participants. Completed in 30 March 2016.

Timeline

13 February 2011

30 March 2016

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	113
Start date	13 February 2011
Estimated completion	30 March 2016
Sites	1 location across Mali

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Urea Breath Test — all drugs for Urea Breath Test →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with Tuberculosis or Urea Breath Test. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Tuberculosis is a disease of the lungs caused by the bacteria Mycobacterium tuberculosis (M. tuberculosis). The most popular and least expensive tool used to detect the presence of the tuberculosis bacteria is called sputum smears, which is a lab test used to look for bacteria in the sputum via a microscope. However, the test s results are not always accurate, and the test cannot determine if the bacteria will be resistant to standard tuberculosis treatments. The most sensitive test currently available is called sputum culture, in which a sputum sample is used to check for the growth of tuberculosis bacteria. However, this test takes at least a month to produce accurate results, and requires expensive equipment that is not available in many countries where M. tuberculosis is found.
* The urea breath test (UBT) has been used to detect infection with Helicobacter pylori, a bacteria associated with stomach ulcers, by testing individual breath samples. Researchers are interested in determining whether breath samples can also be used to detect the presence of M. tuberculosis in the lungs of subjects with tuberculosis, and to see if tuberculosis treatments are successful.

Objectives:

\- To assess the sensitivity and specificity of urea breath testing in the diagnosis and treatment response of pulmonary tuberculosis.

Eligibility:

* Individuals at least 18 years of age who either have been diagnosed with tuberculosis or are healthy volunteers with no past history of tuberculosis.
* The study will be conducted in Bamako, Mali.

Design:

* This study will involve three groups: two pilot groups of individuals who have already been diagnosed with tuberculosis, and a primary study group of both healthy volunteers and individuals who have been diagnosed with tuberculosis.
* Participants will be screened with a physical examination and medical history, as well as blood, sputum, stool, and urine samples.
* First pilot group (one visit):
* Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.
* Participants will provide a baseline exhaled air sample, and then will receive the UBT test, which involves a dose of Pranactin -Citric dissolved in water. Additional exhaled air samples will be collected at eight time points (10, 20, 45, 60, 90, 120, 180, and 240 minutes after the dose).
* Second pilot group (one or two visits):
* Participants should not eat, drink, or smoke for at least 1 hour prior to the UBT test.
* Participants will provide a baseline exhaled air sample, and then will receive the UBT test. Half of the participants will receive a dose of bismuth (Pepto-Bismol) prior to collection of air samples to see how this affects the results of the UBT test. Additional exhaled air samples will be collected at three time points specified by the study researchers.
* On the following day, participants will return for a second visit to provide three more exhaled air samples.
* Primary study group (five visits for participants with tuberculosis, two visits for healthy volunteers):
* All participants will have two visits, following the procedures given for the second pilot group. Half will receive a dose of bismuth prior to collection of air samples.
* Participants with tuberculosis will have three additional visits (days 6, 10, and 16 following the first study visit) to provide additional sputum and exhaled air samples to monitor the progress of tuberculosis treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stool microbiome reveals diverse bacterial ureases as confounders of oral urea breath testing for Helicobacter pylori and Mycobacterium tuberculosis in Bamako, Mali.
   Maiga M, Cohen K, Baya B, Srikrishna G, et al · · 2016 · cited 11× · PMID 27532494 · DOI 10.1088/1752-7155/10/3/036012
2. In vitro and in vivo studies of a rapid and selective breath test for tuberculosis based upon mycobacterial CO dehydrogenase.
   Maiga M, Choi SW, Atudorei V, Maiga MC, et al · · 2014 · cited 7× · PMID 24736224 · DOI 10.1128/mbio.00990-14