Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004401
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-22
First Post:
2023-07-30
Brief Title:
The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Helicobacter pyloriHpis 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 actionIn 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
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 actionIn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None