NCT06004401

The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin and Metronidazole, has increased, leading to the gradual reduction of the eradication rate . In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism of this enzyme activity in the population results in significant individual differences in the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other drugs by affecting the activity of CYP2C19 in the liver. Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan is a representative of this class of drugs. Compared to traditional proton pump inhibitors, it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset time , longer sustained acid inhibition time, and less influence from food consumption. Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid secretion more strongly and persistently, therefore, eradication plans based on vonoprazan are expected to improve the eradication rate of Hp. Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan has a more significant therapeutic effect and higher safety in the treatment of Helicobacter pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there have been reports of successful eradication of multi drug resistant Hp retreated patients with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp. Therefore, the investigators further carried out a prospective single center clinical study and set up a penicillin negative group. One month after treatment, 13C carbon breath test was performed to check the efficacy, in order to explore the efficacy of the combination therapy based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin allergy.

Detailed description

After one month of treatment, a 13C carbon breath test was conducted to investigate the efficacy of a dual therapy based on vorolaxen in eradicating Hp, especially for those allergic to penicillin.

Conditions

• The Eradication Rate of Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Vonopazan +Amoxicillin	Vonopazan 20mg 2//day+Amoxicillin
DRUG	Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin	Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day
DRUG	Vonopazan +Minocycline	Vonopazan 20mg 2/day+Minocycline 100mg 2/day
DRUG	Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin	Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day

Timeline

• Start date: 2023-08-20
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2023-08-22
• Last updated: 2023-08-22