New acid reducer shows promise in fighting stomach bug
NCT ID NCT07606833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether a new acid-reducing drug, anaprazole, works better than the standard drug esomeprazole when used with bismuth and two antibiotics to treat H. pylori infection. About 556 adults in China will take either anaprazole or esomeprazole pills twice daily for 14 days. The main goal is to see if the infection is gone after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anaprazole sodium (a drug that reduces stomach acid) combined with bismuth, amoxicillin, and clarithromycin
- What this could lead to
- If successful, this could provide a new treatment option for H. pylori infection, potentially improving eradication rates.
- What could go wrong
- This is a Phase 3 trial, but results may not apply to all populations. The treatment includes antibiotics, which can cause side effects like diarrhea or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 556 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-75 years 2. During the screening visit, the participants were determined to be Hp-positive by 13C-UBT and Hp eradication therapy was required by the investigator. 3. Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent. Exclusion Criteria: 1. Known allergic history to Anaprazole or Esomeprazole, or amoxicillin or clarithromycin and bismuth(including any related excipients ). 2. Have a history of severe rapid-onset hypersensitivity to β-lactam agents (such as cephalosporins, carbapenems, monocyclic β-lactam). 3. The participant has Zollinger-Ellison syndrome. 4. Participants known to have acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury (AGML) or acute duodenal mucosal injury (ADML). 5. Participants in the trial had previously undergone surgeries or procedures that might affect gastric acid secretion or drug absorption. 6. Participants with a history of malignant tumors within 5 years prior to screening (Cutaneous basal cell carcinoma or cervical carcinoma in situ that has been cured is excluded). 7. The subject has severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine or hematological diseases that the investigator believes may affect the study results and the safety of the participants. 8. Laboratory examination during the screening period showed ALT or AST \> 2 times of the upper limit of normal value, TBIL \> 1.5 times of the upper limit of normal value; renal function Cr \> 1.5 times of the upper limit of normal value (one review was allowed in the study, and those who still did not meet the requirements for inclusion were excluded). 9. Participants with severe arrhythmia, multigenic premature ventricular contractions (PVC), second-degree or higher atrioventricular block, ventricular arrhythmia or prolonged QT interval (QTcF\> 450ms in male and 470ms in female). 10. Previously received Helicobacter pylori eradication treatment. 11. Used PPI or P-CAB preparations within 2 weeks before 13C-UBT examination during the screening period; Antibiotics, bismuth-containing preparations, or traditional Chinese medicine with antibacterial effects were used within 4 weeks before 13C-UBT test during the screening period. 12. Those with chronic drug abuse in the 12 months prior to screening. 13. Those with alcohol dependence in the 12 months prior to screening. 14. Participated used experimental drugs/devices in other drug/device clinical studies within 3 months before screening. 15. Female participants who are suspected or already pregnant, breastfeeding; and female participant or a partner of male participant who are planning to become pregnant during the study. 16. Others were deemed unsuitable for the trial .
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518100, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stomach biopsies could reveal Antibiotic-Resistant h. pylori without extra tests
- Can a Two-Drug combo beat a stubborn stomach bug?
- A 10-Day h. pylori cure? new trial tests a streamlined approach
- Stomach bug tied to belly fat and blood sugar issues?
- New study tests cheaper h. pylori treatment to beat antibiotic resistance
- Could adding bismuth boost stomach bug treatment?