Argon Plasma for Helicobacter Pylori Infection

(HEAPE Trial)

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher C. Thompson, MD, MSc

Must not be taking: Antibiotics, PPIs

Disqualifiers: Pregnancy, Cardiopulmonary disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating H. pylori infections using a special argon plasma-based therapy during stomach examinations. Two methods are compared: one treats the infection directly in the stomach, while the other prepares the treatment outside the body before application. The goal is to determine if these methods, known as HEAPE and Pre-HEAPE, can safely reduce or eliminate the bacteria. Individuals with a confirmed H. pylori infection who plan to undergo an upper endoscopy might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for H. pylori infections.

Will I have to stop taking my current medications?

The trial requires that you stop taking antibiotics or proton pump inhibitors (PPIs) two weeks before the procedure. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that argon plasma coagulation (APC), the technology used in HEAPE and Pre-HEAPE treatments, is generally safe and well-tolerated. Studies have found it effective for treating small stomach issues and other digestive problems, with only minor side effects reported. Most complications, if they occur, are temporary and not serious.

In HEAPE direct, argon plasma is applied directly to the stomach, which might help retain the substances that kill bacteria. Pre-HEAPE treats the solution outside the body, making it easier to handle without needing an endoscope.

These treatments aim to reduce heat-related injury to the stomach lining, which should keep side effects low. While using this method for H. pylori is still under study, existing research on argon plasma's safety in similar treatments is promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Helicobacter pylori infection, which typically involve a mix of antibiotics and acid-reducing medications, the new approaches using Argon Plasma Coagulation (APC) offer a fresh take. Researchers are excited about these treatments because they involve creating Plasma Activated Liquid (PAL), which is either directly generated in the stomach (HEAPE direct) or prepared externally and then administered (Pre-HEAPE). This method directly targets the bacteria in the stomach, potentially reducing the chance of reactive species losing their potency, and offers a novel, non-antibiotic strategy that could avoid issues like antibiotic resistance.

What evidence suggests that this trial's treatments could be effective for H. pylori infection?

Research has shown that treatments using argon plasma, like those in this trial, could effectively treat H. pylori infections. Participants may receive either the HEAPE direct method or the Pre-HEAPE method. Studies have found that argon plasma can reduce harmful bacteria in the stomach by creating reactive particles that kill them, reducing bacteria without harming the stomach lining. The HEAPE direct method targets the bacteria directly in the stomach, helping to maintain these important reactive particles. In contrast, the Pre-HEAPE method prepares the treatment outside the body, simplifying its use during the procedure. Both methods aim to lower H. pylori levels, as indicated by a decrease in urease activity (an enzyme linked to H. pylori) in breath tests before and after treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with H. pylori infection, which can cause stomach ulcers and other gastrointestinal issues. Participants should be suitable for endoscopic procedures. The study excludes those who may not safely undergo the procedure or have conditions that could interfere with treatment outcomes.

Inclusion Criteria

Confirmed untreated H. pylori infection

Available to return for all routine follow-up study visits

I can understand and agree to the study's consent form.

Exclusion Criteria

Pregnancy or puerperium

Lactation

I have a hernia or am at risk of aspiration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the HEAPE procedure, where the stomach is filled with sodium chloride solution treated with APC, followed by antibiotic treatment.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for H. pylori eradication using Urea Breath Test and adverse events are recorded.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HEAPE
• Pre-HEAPE

Trial Overview The trial tests a new argon plasma-based therapy called HEAPE to treat H. pylori during endoscopy, comparing two methods: direct application in the stomach (HEAPE direct) and pre-treatment outside the body (Pre-HEAPE). It aims to see if this can reduce bacteria levels without thermal damage.

How Is the Trial Designed?

Group I: Pre-HEAPE Active Control 1 Intervention

This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.

Group II: HEAPE direct Active Control 1 Intervention

This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.

Who Is Running the Clinical Trial?

Christopher C. Thompson, MD, MSc

Lead Sponsor

Trials

6

Recruited

5,300+

Erbe Elektromedizin GmbH

Industry Sponsor

Trials

14

Recruited

840+

Published Research Related to This Trial

Helicobacter pylori is linked to various gastric diseases, including chronic gastritis and ulcers, and its eradication can lead to healing and reduced antibody levels in affected patients.

The most effective treatment for H. pylori involves a combination of bismuth salts and two antibiotics, although successful eradication is not guaranteed in all cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helicobacter pylori and associated gastroduodenal diseases. Review article. Rautelin, H., Kosunen, TU.[2006]

Helicobacter pylori should be tested and eradicated in specific patient groups, including those with a history of ulcers, chronic dyspepsia, and high risk factors for gastric cancer, to prevent complications before starting NSAIDs treatment.

The Urea Breath Test is the most reliable method for diagnosing H. pylori infection, and in areas with high antibiotic resistance, new treatment regimens like sequential therapy or bismuth-containing quadruple therapies are recommended over standard triple therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New recommendations for the diagnosis and the treatment of Helicobacter pylori infection]. de Korwin, JD.[2020]

Helicobacter pylori (H.p.) eradication is crucial for treating conditions like peptic ulcers and certain types of gastric lymphoma, but it does not improve symptoms of non-ulcer dyspepsia, highlighting the need for targeted treatment based on specific indications.

First-line treatments for H.p. infection typically involve a proton pump inhibitor (PPI) or ranitidine bismuth citrate combined with two antibiotics, with clarithromycin and amoxicillin being the most effective, although resistance to metronidazole is a growing concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of Helicobacter pylori infections]. Hentschel, E.[2020]

Argon plasma coagulation (APC) therapy has become an important and effective treatment in gastrointestinal endoscopy, with recent studies showing its efficacy in various gastrointestinal disorders.

The complication rates associated with APC are low, indicating it is a well-tolerated option; however, more clinical trials are needed to compare APC with other treatments and assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation therapy. Manner, H.[2014]

In a study of 99 patients with solitary rectal ulcer syndrome (SRUS), argon plasma coagulation (APC) significantly improved bleeding control and ulcer healing compared to conventional therapy, with 75.6% response in the APC group versus 29.3% in the control group.

After 3 months, 70.7% of patients treated with APC showed continued healing of ulcers, compared to only 10.3% in the conventional therapy group, indicating that APC is an effective intervention for managing SRUS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial. Zergani, FJ., Shaiesthe, AA., Hajiani, E., et al.[2020]

In a study involving 13 children with significant health issues, argon plasma coagulation was effective in achieving hemostasis in 8 out of 12 cases of bleeding lesions, demonstrating its efficacy in pediatric endoscopy.

The procedure had a low complication rate, with only 17% of patients experiencing minor issues, indicating that argon plasma coagulation is a safe option for managing bleeding and tissue ablation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation: Clinical experience in pediatric patients. Khan, K., Schwarzenberg, SJ., Sharp, H., et al.[2017]

The European Helicobacter pylori Study Group recommends using non-invasive tests like the urea breath test (UBT) and antigen stool assay for diagnosing H. pylori in low-risk patients, emphasizing their effectiveness in the 'test and treat strategy'.

For confirming the eradication of H. pylori after treatment, the UBT is preferred, with the stool antigen assay as a backup, highlighting the importance of accurate follow-up testing to ensure successful treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diagnosis of helicobacter pylori infection: guidelines from the Maastricht 2-2000 Consensus Report]. Pellicano, R., Fagoonee, S., Palestro, G., et al.[2020]

The high power argon plasma coagulation system demonstrated safety and efficacy in treating various upper gastrointestinal conditions, with only minor complications occurring in 8.7% of treatment sessions and major complications in just 1.1%.

With a mean of 1.46 treatment sessions required, this system proved to be effective for tumor debulking, suggesting it could serve as a viable alternative to Nd:YAG laser therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new high power argon plasma coagulation system (hp-APC) in lesions of the upper gastrointestinal tract. Manner, H., May, A., Faerber, M., et al.[2013]

In a study of 41 patients with bleeding peptic ulcers, argon plasma coagulation was found to achieve faster hemostasis compared to the heater probe, with an average time of 60 seconds versus 115 seconds.

Both treatments showed similar rates of initial hemostasis, recurrent bleeding, and 30-day mortality, indicating that argon plasma coagulation is a safe and effective option for managing bleeding peptic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective comparison of argon plasma coagulator and heater probe in the endoscopic treatment of major peptic ulcer bleeding. Cipolletta, L., Bianco, MA., Rotondano, G., et al.[2019]

Helicobacter pylori is a significant cause of chronic gastritis and is linked to peptic ulcers and gastric cancer, making its detection and eradication crucial for patients with peptic ulcers to improve their condition.

Current treatment regimens for eradicating H. pylori can be simplified; effective options like omeprazole combined with amoxicillin or clarithromycin are better tolerated than traditional triple therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helicobacter pylori. Fennerty, MB.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06529159

H. Pylori Eradication With Argon Plasma During Endoscopy The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during ...

2. trialx.com trialx.com/clinical-trials/listings/301116/h-pylori-eradication-with-argon-plasma-during-endoscopy/

H. Pylori Eradication With Argon Plasma During Endoscopy The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori ...

3. giejournal.org giejournal.org/article/S0016-5107(24)00045-2/abstract

Clinical outcomes of argon plasma coagulation for the ... This study included 911 patients who underwent APC for gastric neoplasms at the tertiary hospital from July 2007 to March 2022 with a minimal follow-up of 12 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4160620/

Comparison of Hemostatic Efficacy of Argon Plasma ... Endoscopic therapy with APC plus distilled water injection was no more effective than APC alone in treating high-risk bleeding ulcers.

5. researchgate.net researchgate.net/publication/232265966_Helicobacter_pylori_infection_and_coagulation_in_healthy_people

Helicobacter pylori infection and coagulation in healthy ... 4 We investigated the potential association between H pylori infection and abnormalities of plasma coagulation in healthy people, with ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510724000452

Clinical outcomes of argon plasma coagulation for the ... Argon plasma coagulation (APC) could be considered a treatment modality for small gastric low-grade dysplasia (LGD) instead of endoscopic resection.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11967395/

Pathological Evaluation of the Therapeutic Effects of Argon ... Argon plasma coagulation is safe and effective for treating smaller gastric lesions with low-grade dysplasia: a comparison with endoscopic ...

8. researchgate.net researchgate.net/publication/377638057_Clinical_outcomes_of_argon_plasma_coagulation_for_the_treatment_of_gastric_low_grade_dysplasia

Clinical outcomes of argon plasma coagulation for the ... Helicobacter pylori infection is one of the most common infectious diseases worldwide. ... heat probe coagulation versus epinephrine injection plus argon plasma ...