Screening and Treatment for Helicobacter Pylori Infection

Overseen By Sarahane Joanem

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Disqualifiers: Pregnancy, Breastfeeding, Planning pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

75 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

Participants in Aim 1 that received a positive result for H. Pylori (HP) testing

Participants are advised to only begin re-testing procedures in Aim 2 if they have finished the medication regimen for HP treatment at least 6 weeks ago

Exclusion Criteria

Pregnant women

Those who are breastfeeding

Those who are planning to become pregnant/breastfeed

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants who test positive for H. pylori receive treatment to eradicate the infection

6 weeks

Retesting

Participants undergo retesting to confirm eradication of H. pylori infection

6 weeks after treatment

1 visit (in-person or at-home)

Follow-up

Participants are monitored for safety and effectiveness after retesting

4 weeks

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?

Group I: At-Home Retesting Strategy Experimental Treatment 1 Intervention

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.

Group II: Standard Care Retesting Strategy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Phathom Pharmaceuticals

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8578164/

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 ...

2. drugs.com drugs.com/pro/pytest.html

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.

3. mdpi.com mdpi.com/2075-4418/12/10/2428

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.pdf

PYtest (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 ...

5. brieflands.com brieflands.com/journals/jjm/articles/61884

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).

6. mayoclinic.org mayoclinic.org/drugs-supplements/14c-urea-oral-route/description/drg-20066608

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.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK542286/

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 ...

8. guidelinecentral.com guidelinecentral.com/drug/13148b04-9295-41bb-bd8b-76dbd4ce7c00/pytest

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 ...

9. drugs.com drugs.com/cons/14c-urea.html

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.