Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749081
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-02-18
Brief Title:
Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy
Sponsor:
The First Affiliated Hospital of Nanchang University
Organization:
The First Affiliated Hospital of Nanchang University
Study Overview
Official Title:
Lacidophilin Tablets in Combination With Vonorazan and Amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection a Prospective Multi-centers Superiority Double-blind Randomized Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
Our previous study included 119 Helicobacter pyloriH pylori-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either bid or tid plus vonoprazan 20 mg bid for 7 or 10 days Neither 7-or 10-day VA dual therapy with either bid or tid amoxicillin achieved satisfied efficacy ie 90 when given as first-line treatment for H pylori infection Lacidophilin tablets have been reported to increase the eradication rate of H pylori while reducing the incidence of adverse effectsThis study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H pylori in China
Detailed Description:
This study was designed as a prospective multi-centers double-blind randomized superiority clinical study and was conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials
Consecutive H pylori-infected subjects ages from 18 to 70 without eradication history were recruited H pylori infection was confirmed by immunohistochemistry or urea breath test
The H pylori-infected subjects were randomly assigned to receive lacidophilin tablets or placebo in combination with amoxicillin-vonoprazan dual therapy for in a 11 allocation ratio a randomization list was generated using Statistical Product Service Solutions version 250
The therapy consisted of 2400mg lacidophilin tablets or placebo three times daily 1000 mg amoxicillin capsules three times daily and 20mg vonoprazan fumarate tablets twice daily for 10 days The shape taste packaging storage method and administration method of placebo are the same as lacidophilin tablets Participants and investigators were blinded to the allocated treatment group
At the start the detailed demographics and characteristics of the subjects included in this study were recorded including sex age nationality height weight education status dwelling area history of smoking and alcohol concomitant diseases and medication history In addition physical examinations and assessment of vital signs were performed Gastric antrum and body biopsy of the included subjects were obtained during the endoscopy which were followed by culture and susceptible test of antibiotics Fecal sample was collected before eradication
During or after treatment-emergent adverse events TEAEs and concomitant medication were recorded throughout the study including bloating nausea vomiting abdominal pain diarrhea constipation skin rash headache hunger sensation and others All TEAEs were divided into mild moderate and severe TEAEs leading to study drug discontinuation were also recorded Fecal sample was collected after eradication
The confirmation of H pylori status was evaluated by 13C-urea breath test 4-8 weeks after treatment H pylori status was considered as negative or positive according to the instructions of the manufacturer Oral and fecal sample was collected at the timepoint of recheck
Consecutive H pylori-infected subjects ages from 18 to 70 without eradication history were recruited H pylori infection was confirmed by immunohistochemistry or urea breath test
The H pylori-infected subjects were randomly assigned to receive lacidophilin tablets or placebo in combination with amoxicillin-vonoprazan dual therapy for in a 11 allocation ratio a randomization list was generated using Statistical Product Service Solutions version 250
The therapy consisted of 2400mg lacidophilin tablets or placebo three times daily 1000 mg amoxicillin capsules three times daily and 20mg vonoprazan fumarate tablets twice daily for 10 days The shape taste packaging storage method and administration method of placebo are the same as lacidophilin tablets Participants and investigators were blinded to the allocated treatment group
At the start the detailed demographics and characteristics of the subjects included in this study were recorded including sex age nationality height weight education status dwelling area history of smoking and alcohol concomitant diseases and medication history In addition physical examinations and assessment of vital signs were performed Gastric antrum and body biopsy of the included subjects were obtained during the endoscopy which were followed by culture and susceptible test of antibiotics Fecal sample was collected before eradication
During or after treatment-emergent adverse events TEAEs and concomitant medication were recorded throughout the study including bloating nausea vomiting abdominal pain diarrhea constipation skin rash headache hunger sensation and others All TEAEs were divided into mild moderate and severe TEAEs leading to study drug discontinuation were also recorded Fecal sample was collected after eradication
The confirmation of H pylori status was evaluated by 13C-urea breath test 4-8 weeks after treatment H pylori status was considered as negative or positive according to the instructions of the manufacturer Oral and fecal sample was collected at the timepoint of recheck
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