Testing the effectiveness of the PyloPlus Urea Breath Test for H. pylori after treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, non-randomized, open-label study designed to evaluate the efficacy of the PyloPlus Urea Breath Test (UBT) system in confirming the eradication of Helicobacter pylori infection after treatment. Eligible participants, who have been treated for H. pylori within the past six months, will undergo testing using non-radioactive 13C-Urea and may provide stool samples or undergo endoscopy for additional testing. The results from the PyloPlus UBT will be compared against established methods such as the H. pylori Stool Antigen Test and Rapid Urease Test to assess its accuracy and reliability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or Female at least 18 years of age
* Patients who have been diagnosed with H. pylori and have been treated within the past 6 months
* Naive to H. pylori treatment in the past 4 weeks (including PPIs)

Exclusion Criteria:

* Pregnant and/or lactating women.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Participation in other interventional trials.
* Allergy to test substrates.
* Antibiotics taken within 4 weeks of the testing.
* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food

Where it's running

• Dolphin Medical Research
  Doral, Florida, United States Recruiting
• Hudson County Clinical Trials Research Center
  Union City, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Manager
• Email: info@gulfcoastscientific.com
• Phone: 877-855-4100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fecal transplant to help eradicate stubborn Helicobacter pylori infection

  This study tests whether giving a fecal microbiota transplant can help people with Helicobacter pylori infection that has not responded to standard treatments.

  Recruiting Phase 4 Sichuan Provincial People's Hospital · Chengdu, Sichuan · NCT07704255

• Fecal-guided simplified vonoprazan plus clarithromycin first-line therapy for H. pylori

  We are testing whether a two-drug regimen of vonoprazan plus clarithromycin clears H. pylori in adults whose fecal PCR shows no clarithromycin resistance mutations.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07439445

• Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection

  This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.

  Recruiting Kaohsiung Medical University · Kaohsiung City · NCT07358130

• P-CABs plus bismuth quadruple treatment for Helicobacter pylori infection

  This study tests whether using potassium-competitive acid blockers (P-CABs) in bismuth-containing quadruple therapy works better and is safe for adults with H. pylori infection.

  Recruiting Qilu Hospital of Shandong University · Jinan · NCT07285096

• Bismuth versus no bismuth for treating H. pylori-related stomach and duodenal ulcers in children

  This project will try adding bismuth to standard antibiotic and PPI treatment to see if it helps clear H. pylori and heal ulcers in children.

  Recruiting Can Tho University of Medicine and Pharmacy · Can Tho · NCT07260006

• Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication

  This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.

  Recruiting Phase 2/3 First People's Hospital of Hangzhou · Hangzhou, Zhejiang · NCT07242456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.