Screening and Treatment for Helicobacter Pylori Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial screens and treats individuals for a stomach infection called Helicobacter pylori (H. pylori), which can cause serious conditions like gastritis, peptic ulcers, and stomach cancer. Participants who test positive will either use an at-home breath test kit or visit a clinic for retesting after treatment. The breath test involves swallowing a capsule and then providing a breath sample to check for infection. This trial suits those who have already tested positive for H. pylori and completed their treatment at least six weeks ago. As a Phase 4 trial, the treatment is FDA-approved and proven effective, aiming to understand how it benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have completed their H. pylori treatment at least 6 weeks before re-testing.
What is the safety track record for the PYTEST® 14C-Urea Capsule Breath Test?
Research has shown that the PYTEST® 14C-Urea Capsule Breath Test is generally safe for diagnosing H. pylori infection. The test uses a tiny amount of radiation, which remains within safe limits. As a non-invasive test, it avoids surgery or complicated procedures.
This test detects a specific enzyme in the stomach associated with H. pylori. Swallowing the capsule triggers a reaction if the bacteria are present, which can be detected in the breath. This method is simple, quick, and reliable for identifying the infection.
Overall, studies have reported that the PYTEST® 14C-Urea Capsule Breath Test is well-tolerated, with no significant side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the PYTEST® 14C-Urea Capsule Breath Test because it offers a non-invasive and convenient way to diagnose Helicobacter pylori (H. pylori) infections. Unlike traditional methods that often require endoscopy or biopsies, this test involves simply swallowing a capsule and collecting a breath sample. The at-home retesting option allows participants to complete the test in the comfort of their own space, making it more accessible and less stressful. These features could improve patient compliance and allow more people to get tested and treated for H. pylori infections effectively.
What evidence suggests that this trial's treatments could be effective for H. pylori infection?
Research shows that the PYTEST 14C-Urea Breath Test, used by participants in this trial, reliably detects H. pylori infection in the stomach. The test identifies an enzyme linked to H. pylori. It is simple and non-invasive, requiring participants to swallow a capsule and then provide a breath sample for analysis. Studies have demonstrated its high accuracy, with a sensitivity of 94.9% and a specificity of 100%. This accuracy ensures excellent identification of the infection, aiding in diagnosis. Treating H. pylori once detected can help prevent serious conditions like stomach inflammation and stomach cancer.26789
Who Is on the Research Team?
Shria Kumar, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for individuals in South Florida who previously tested positive for H. pylori infection and have completed treatment at least 6 weeks ago. It's not open to pregnant or breastfeeding women, or those planning to become pregnant or breastfeed soon.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants who test positive for H. pylori receive treatment to eradicate the infection
Retesting
Participants undergo retesting to confirm eradication of H. pylori infection
Follow-up
Participants are monitored for safety and effectiveness after retesting
What Are the Treatments Tested in This Trial?
Interventions
- PYTEST® 14C-Urea Capsule Breath Test
Trial Overview
The study tests if a home-administered breath test (PYTEST®) can effectively screen and monitor the presence of H. pylori after treatment, compared to the standard in-person retesting method.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants who test positive for H. pylori (HP), will receive a kit that contains a PYtest® 14C-Urea Breath Test (TriMed). Participants will complete the retest at-home at least 6 weeks after treatment. Study team will contact the participant to inquire about retesting and the post treatment survey. The kit will include an envelope, materials for the test, and a return form. PYtest® is a quantitative and non-invasive method for the diagnosis of HP. The test is conducted with the swallowing of a urea capsule. If gastric urease from HP is present, the urea is split to form carbon dioxide and ammonia. Ten minutes after the capsule is ingested, a breath sample is collected in a balloon. The balloon is tied and mailed along with the return form to be analyzed by an outside laboratory. The study team will call the participant to provide results. Those who retest positive will be instructed to seek treatment from their primary care provider.
Participants who test positive for H. pylori (HP), will complete their retest in-person with the study team. Study team will contact the participant to inquire about scheduling the retest and the post treatment survey. Retest will be completed in Don Soffer or at one of study's community sites. PYtest® is a urea breath test and is a quantitative and non-invasive method for the diagnosis of HP. The test is conducted with the participant swallowing a urea capsule. If gastric urease from HP is present, the urea is split to form carbon dioxide and ammonia. Ten minutes after the capsule is ingested by the participant, a breath sample is collected in a balloon. This liquid is analyzed on site by the liquid scintillation counter, by the study team. Those who test positive will be instructed to seek treatment for H. pylori infection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
NRG Oncology
Collaborator
Phathom Pharmaceuticals
Collaborator
Citations
A simple, rapid, and highly reliable capsule-based 14C ...
Supplying the 14C-urea in a capsule obviates the problem of false-positive results in early breath samples and makes it possible to diagnose H. pylori ...
PYtest: Package Insert / Prescribing Information
PYtest1 (14C-Urea Breath Test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of H.pylori infection in the human stomach.
14 C-Urea Breath Tests in the Diagnosis of Helicobacter ...
The sensitivity and specificity of 13C/14C-urea breath tests in the diagnosis of H. pylori infection ranged between 64–100% and 60.5–100%, respectively. The ...
4.
radiopharmaceuticals.info
radiopharmaceuticals.info/uploads/7/6/8/7/76874929/pytest_capsule_pi_2022.pdfPYtest (14C-Urea Capsules) - Radio Rx
PYtest ( C-Urea breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of H. pylori infection in the human stomach. The ...
Investigation of Helicobacter pylori Infection Prevalence ...
The C14-urea breath test (C14-UBT) is a rapid, well-tolerated, non-invasive method to detect H. pylori, with a sensitivity of 94.9% and specificity of 100% (1).
14c urea (oral route) - Side effects & dosage
However, with the small amounts in the capsule that is used for the test, the radiation your body receives is very low and is considered safe.
Urea Breath Test - StatPearls - NCBI Bookshelf
A simple, rapid, and highly reliable capsule-based 14C urea breath test for diagnosis of Helicobacter pylori infection. Scand J ...
Urea, C-14 (PYtest) Drug Information
( 14C-Urea breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of H. pylori infection in the human stomach. The test ...
14c urea Advanced Patient Information
Urea C 14 is a radiopharmaceutical. It is used to diagnose stomach ulcers caused by a certain kind of bacteria known as Helicobacter pylori or H. pylori.
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