Carbon 13 urea breath test as a novel technique in the diagnosis of pulmonary tuberculosis

Abstract

Background

The Urea Breath Test (UBT) is the golden standard of investigation for Helicobacter pylori. Tuberculosis is common and endemic in Iraq, with limited investigations. This study was conducted to determine the safety and importance of UBT as a method for the diagnosis of active pulmonary tuberculosis.

Material and method

A prospective, case-control study trial was conducted to determine the safety of 75 mg of inhaled C13-urea in 50 healthy participants. Then, in national TB, Over the course of a one-year study at a medical city in Baghdad, 50 participants with confirmed active pulmonary tuberculosis were enrolled. The safety of inhaled C13-urea was assessed by physical examination and spirometry. The C13-urea was administered by using a jet nebulizer, followed by the collection of exhaled breath at 15 and 30 min’ post-inhalation. A double-beam infrared spectrophotometer examined the isotopic ratio of (C13) CO2 to (C12) CO2.

Results

The lung function test, which included forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1), did not show any changes that were clinically significant when healthy people and people with pulmonary tuberculosis (PTB) were compared to their baseline values. Additionally, there was no recorded incidence of adverse events among both healthy individuals and those with pulmonary tuberculosis (PTB). After 15 min of the nebulization process, the delta over baseline (DOB) means of the control group and PTB patients were −1.2381 ± 1.8392 and 4.8215 ± 5.1889, respectively. After 15 min of the nebulization process, the DOB means of the control group and PTB patients were −1.9628 ± 3.0717 and 3.5686 ± 3.8484, respectively.

Conclusion

Inhaling 13 C-urea seemed safe. DOB values in PTB patients were greater than in controls. Preliminary data suggest that DOB values at 15 min were higher than 30 min. This has potential for diagnosing Mycobacterium tuberculosis.