search
Back to results

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

Primary Purpose

Gastritis, Dyspepsia, Helicobacter Pylori Infection

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Amoxicillin
Bismuth
Esomeprazole
Amoxicillin
Clarithromycin
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy, Intestinal Microecology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 70 years, regardless of gender. Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy. Voluntary Hp eradication therapy. Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends. Exclusion Criteria: Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy. Patients with contraindications to or allergies to the study drug. Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection) Pregnant and lactating women. Having undergone upper gastrointestinal surgery. Have symptoms of dysphagia. Evidence of bleeding or iron deficiency anemia. History of malignancy. History of drug or alcohol abuse within the last 1 year. Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100 mg/d) Those with psychiatric disorders. Received other clinical trials within the past 3 months Refusal to sign the informed consent form.

Sites / Locations

  • Xijing Hosipital of Digestive DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-dose dual therapy

Bismuth Quadruple Therapy

Arm Description

Esomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks.

Esomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks.

Outcomes

Primary Outcome Measures

Changes in the diversity and structure of fecal microbiota
Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens.

Secondary Outcome Measures

Eradication rate of Helicobacter pylori
The end point of this study is H.pylori eradication,established by negative [13C] urea breath test (DOB value below 3.9)28 days after the end of eradication.

Full Information

First Posted
February 3, 2023
Last Updated
February 14, 2023
Sponsor
Xijing Hospital of Digestive Diseases
search

1. Study Identification

Unique Protocol Identification Number
NCT05742568
Brief Title
Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
Official Title
Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.
Detailed Description
The trial can be divided into three phases. Enrollment screening phase: patients who had been clearly diagnosed with Hp infection and had not received antibiotic therapy and met the inclusion and exclusion criteria were informed and signed informed consent forms, their basic data information was collected, medical history and laboratory tests before enrollment were taken; if they met the requirements of the trial protocol they were included in the study, and patients' stools were collected for 16S rRNA gene sequencing. Treatment period: Patients were enrolled according to a randomized number table provided in advance by a third party, and patients were randomized in a 1:1 ratio to high-dose diphtherapy and bismuth quadruple therapy to receive 2 weeks of Hp eradication treatment. During the treatment period, patients were provided with written instructions on how to take the medication, instructed on the correct way to take the medication, and improved their compliance; patients were asked to record their symptoms and adverse reactions during the medication period, and were informed of the visiting telephone number and visiting WeChat, so that they could keep in touch with the investigator at any time. Follow-up period: At the end of treatment (i.e., day 14 from the start of treatment), patients were asked to return at that time to have their stools sequenced for 16S rRNA gene, and 6 weeks after the end of treatment (i.e., day 56 from the start of treatment), patients were asked to return at that time to undergo rapid urease test (RUT), 13C/14C-urea breath test (13C/14C-UBT), or fecal Hp antigen test. ) or fecal Hp antigen assay (HpSA), with the results recorded on a CRF form, and the patient's stool collected for 16S rRNA gene sequencing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis, Dyspepsia, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer
Keywords
Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy, Intestinal Microecology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose dual therapy
Arm Type
Experimental
Arm Description
Esomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks.
Arm Title
Bismuth Quadruple Therapy
Arm Type
Active Comparator
Arm Description
Esomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
High-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID plus amoxicillin 500 mg 2 capsules TID
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxy
Intervention Description
High-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 20mg 2 tablet TID
Intervention Type
Drug
Intervention Name(s)
Bismuth
Intervention Description
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
BBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
Primary Outcome Measure Information:
Title
Changes in the diversity and structure of fecal microbiota
Description
Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens.
Time Frame
before treatment,1day after treatment,6 weeks after treatment
Secondary Outcome Measure Information:
Title
Eradication rate of Helicobacter pylori
Description
The end point of this study is H.pylori eradication,established by negative [13C] urea breath test (DOB value below 3.9)28 days after the end of eradication.
Time Frame
28 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 70 years, regardless of gender. Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy. Voluntary Hp eradication therapy. Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends. Exclusion Criteria: Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy. Patients with contraindications to or allergies to the study drug. Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection) Pregnant and lactating women. Having undergone upper gastrointestinal surgery. Have symptoms of dysphagia. Evidence of bleeding or iron deficiency anemia. History of malignancy. History of drug or alcohol abuse within the last 1 year. Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100 mg/d) Those with psychiatric disorders. Received other clinical trials within the past 3 months Refusal to sign the informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tengteng Wang
Phone
86-18891515679
Email
18891515679@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongquan Shi, Ph. D
Phone
86-29-84771515
Email
shiyquan@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongquan Shi, Ph. D
Organizational Affiliation
Xijing Hosipital of Digestive Disease
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hosipital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongquan Shi, Ph. D
Phone
86-29-84771515
Email
shiyquan@fmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology

We'll reach out to this number within 24 hrs