Back to resultsThe Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication
Primary Purpose
Helicobacter Pylori Infection, Infections, Intestinal Bacteria Flora Disturbance
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vonoprazan
Amoxicillin
probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
Eligibility Criteria
Inclusion Criteria: Ages between 18 and 65 years; Sexes eligible for study: both; patients who are diagnosed with Helicobacter pylori; treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months; voluntary to be involved in the study and written informed consent was obtained from all patients Exclusion Criteria: allergic reactions to the study drugs; patients with peptic ulcer; patients who underwent eradication therapy for Helicobacter pylori during the last six months; patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment; patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants; patients who have history of esophageal or gastric surgery; pregnant or lactating women; patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies; Alcohol abusers
Sites / Locations
- Nanjing First Hospital, Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Amoxicillin combined with vonoprazan
Probiotics combined with vonoprazan and amoxicillin
Arm Description
The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days
The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days.
Outcomes
Primary Outcome Measures
The comparison of the gut microbiota composition
Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages.
Secondary Outcome Measures
Helicobacter pylori eradication rate
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Adverse event
adverse events are recorded by the patient
Full Information
NCT ID
NCT05658055
First Posted
December 6, 2022
Last Updated
February 7, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05658055
Brief Title
The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication
Official Title
The Effect of Probiotics With Vonoprazan-amoxicillin Dual Therapy on Gut Microbiotain After Helicobacter Pylori Eradication: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Infections, Intestinal Bacteria Flora Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amoxicillin combined with vonoprazan
Arm Type
Active Comparator
Arm Description
The subjects will be given 20mg vonoprazan twice a day and 1000mg amoxicillin three times a day. These two drugs were taken continuously for 14 days
Arm Title
Probiotics combined with vonoprazan and amoxicillin
Arm Type
Experimental
Arm Description
The subjects will be given 20mg vonoprazan twice a day, 1000mg amoxicillin three times a day and probiotics three times a day. These three drugs were taken continuously for 14 days.
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Intervention Description
Potassium-competitive acid blocker
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Antibiotic for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
probiotics
Intervention Description
Medilac-S; Enterococcus faecium 4.5*10^8 and Bacillus subtilis 5.0*10^7, Hanmi,Beijing, China
Primary Outcome Measure Information:
Title
The comparison of the gut microbiota composition
Description
Stool samples were collected at the points of before eradication, after eradication and at confirmation. The gut microbiota composition of individuals was analyzed by 16S rRNA gene sequencing. Microbiome bioinformatics were performed with QIIME2 and R packages.
Time Frame
12mouth
Secondary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Time Frame
four to six weeks after completion of the medication
Title
Adverse event
Description
adverse events are recorded by the patient
Time Frame
one week after completion of the medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages between 18 and 65 years; Sexes eligible for study: both;
patients who are diagnosed with Helicobacter pylori;
treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
voluntary to be involved in the study and written informed consent was obtained from all patients
Exclusion Criteria:
allergic reactions to the study drugs;
patients with peptic ulcer;
patients who underwent eradication therapy for Helicobacter pylori during the last six months;
patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
patients who have history of esophageal or gastric surgery;
pregnant or lactating women;
patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
Alcohol abusers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenyu Zhang
Phone
+86 025-87726248
Email
zzy6565@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunfan Dong
Phone
+86 18795993220
Email
dyf967878@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
Phone
+86 025-87726248
Email
zzy6565@sina.com
First Name & Middle Initial & Last Name & Degree
Zhibing Wang
Phone
+86 025-87726248
Email
ahwangzhibing776@163.com
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
First Name & Middle Initial & Last Name & Degree
Zhibing Wang
First Name & Middle Initial & Last Name & Degree
Yunfan Dong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication
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