Urea Breath Test for Detecting H. pylori Infection
The urea breath test is a non-invasive, fast, and extremely accurate (95% sensitivity and specificity) to detect the presence of active H. pylori infection. Peer reviews consistently rank the urea breath test as the best method to detect H. pylori infection for differential diagnosis of peptic ulcer disease and chronic active gastritis. The test is also ideal for monitoring therapeutic outcomes and confirmation of cure.
This simple procedure requires administering a challenge substrate that is a non-radioactive 13C urea, collecting patients’ breath samples, and sending the samples to our lab for measurement of 13C enrichment levels. Test kits can be used in your office or sent home with your patient. A prepaid mailer to return the breath samples to the lab comes with each kit. Upon arrival, tests are analyzed and a report faxed or emailed to you on the same day.
There are no dietary modifications and only a one hour fast prior to starting the test. Patients should avoid certain medications and medical procedures. Please read the urea breath test preparation information.
The test kit is designed to be used by patients or staff with no previous experience. The process begins by taking a baseline breath sample by blowing up the blue breath bag collection device. Secure the white cap on the mouthpiece until a click is heard. The next step is to dissolve the urea challenge dose in water and drink it. The last step is to take 1 additional breath sample in the pink collection bag 15 minutes after finishing drinking the urea. Again, secure the white cap on the mouthpiece until a click is heard. Please read the complete urea breath test instructions for more information.
The CDC reports that H. pylori is common worldwide. Estimated prevalence is 70% in developing countries and 30%–40% in the United States and other industrialized countries. It affects both adults and children. Age, exposure to contaminated food and water, poor hygiene, living with someone who has previously been diagnosed with H. pylori, and exposure to contaminated sewage all play a role in H. pylori infection.
The initial sign of peptic ulcer disease is an upset stomach. The epigastric pain is often described as burning or gnawing that goes through to the back. Pain comes several hours after a meal when the stomach is empty and is often worse at night. The epigastric pain lasts from a few minutes to several hours and may be relieved by food, antacids or vomiting.
Other symptoms include:
- Gas (burping)
- Abdominal bloating
- Appetite loss
The diagnostic drug component of the urea breath test kit is 13C-urea contained in a granulated power (Pranactin®-Citric). Each three (3) gram dose of Pranactin-Citric contains 75 mg 13C-urea, citric acid, aspartame and mannitol. The Pranactin-Citric powder is mixed with potable water for oral ingestion by the patient. A baseline breath sample and a 15-minute Post-Dose breath sample are collected into breath bags.
In the presence of H. pylori organism, urea is converted by the bacterial enzyme urease to 13CO2 and ammonia. The 13CO2 is absorbed in the blood and then exhaled in the breath. This results in an increase in the ratio of 13CO2 to 12CO2 in expired breath in the Post-Dose breath sample. In the absence of H. pylori, the Post-Dose breath sample has essentially the same amount of 13CO2 as the baseline breath.
Traditional therapy for H. pylori infection consists of 10 days to 2 weeks of one or two effective antibiotics, such as amoxicillin, tetracycline (not to be used for children <12 yrs.), metronidazole, or clarithromycin, plus either ranitidine bismuth citrate, bismuth subsalicylate, or a proton pump inhibitor. Acid suppression by the H2 blocker or proton pump inhibitor in conjunction with the antibiotics helps alleviate ulcer-related symptoms (i.e., abdominal pain, nausea), helps heal gastric mucosal inflammation, and may enhance efficacy of the antibiotics against H. pylori at the gastric mucosal surface. Currently, eight H. pylori treatment regimens are approved by the Food and Drug Administration (FDA) (Table 1); however, several other combinations have been used successfully. Antibiotic resistance and patient noncompliance are the two major reasons for treatment failure. Eradication rates of the eight FDA-approved regimens range from 61% to 94% depending on the regimen used. Overall, triple therapy regimens have shown better eradication rates than dual therapy. Longer length of treatment (14 days versus 10 days) results in better eradication rates.
Many natural remedies have also been suggested and have shown to have efficacy. For example, a Japanese study in April 2009 found that broccoli is an effective natural remedy of the H. pylori bacteria. It is thought that sulforphanes found in broccoli sprouts have antimicrobial properties. In 1998, an Israeli study found that extracts of cinnamon inhibited urease enzymes from catalyzing reactions in H. pylori cells. There are several other substances that have been offered to counteract H. pylori including herbs like garlic and ginger, oils such as coconut and oregano oil and apple cider vinegar.
For more urea breath test resources, visit our Learning Center.
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