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Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

Primary Purpose

H.Pylori Gastrointestinal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Probiotics packets
Placebo packets
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for H.Pylori Gastrointestinal Disease focused on measuring supplementary pylori, Bismuth quadruple therapy, H. pylori eradication

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients older than 20 years-old underwent documented non-Bismuth containing 1st line H. pylori eradication with failure defined by positive 13C-Urea Breath Test (13C-UBT) at least 6 weeks after completion of therapy is eligible to the study.

Exclusion Criteria:

  1. History of gastrectomy, surgery in the small intestine or colon
  2. History of gastric malignancy, including adenocarcinoma or lymphoma
  3. Allergic history, history of severe adverse effects or contraindication to antibiotics (Tetracycline, Metronidazole ), proton pump inhibitor, or probiotics
  4. Pregnant or lactating women
  5. Severe concurrent chronic or acute disease (e.g. renal failure, liver cirrhosis, or active malignancy)
  6. Concomitant use of clopidogrel or warfarin
  7. Recent (<4 weeks) use of antibiotics, or recent (<4 weeks) probiotic use duration >2 weeks
  8. Not able to give consent on blinding or randomizatio
  9. Not able to give consent by his or herself

Sites / Locations

  • National Taiwan University Hospital Yunlin BranchRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Taiwan University HospitalRecruiting
  • National Taiwan University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics packets

Placebo packets

Arm Description

Probiotics contains 450 billion colony-forming units per packet. The compositions are maltose, lactic acid bacteria and bifidobacteria blend, cornstarch, silicon dioxide.

The compositions are maltodextrin, silicon dioxide, sucralose

Outcomes

Primary Outcome Measures

Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Adverse events are collected
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Adverse events are collected

Secondary Outcome Measures

Eradication rate of second line BQT between two groups
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Re-infection rate 1 year and 3 years after second line eradication therapy
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Eradication rate of second line BQT between two groups
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Eradication rate of second line BQT between two groups
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Re-infection rate 1 year and 3 years after second line eradication therapy
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Re-infection rate 1 year and 3 years after second line eradication therapy
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.

Full Information

First Posted
June 14, 2021
Last Updated
October 19, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05577572
Brief Title
Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic
Official Title
The Effect of Supplementary Probiotic in the Dysbiosis of Gut Microbiota Caused by Second Line Bismuth Containing Quadruple Therapy in Helicobacter Pylori Eradication- A Multicentered, Randomized Double Blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2021 (Actual)
Primary Completion Date
April 29, 2023 (Anticipated)
Study Completion Date
April 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

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
This study is designed to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication
Detailed Description
The role of Helicobacter pylori infection in the development of peptic ulcer disease and gastric cancer have been studied extensively. Eradication of H. pylori decreases the incidence of peptic ulcer and also gastric cancer. First line therapies for H. pylori eradication with PPI and antibiotic combinations considering local clarithromycin resistant rate reaching successful rates above 90%. Bismuth containing quadruple therapy (BQT), as a major choice of second line therapy, is widely prescribed but with considerable gastrointestinal side effects including diarrhea, nausea, vomiting, bloating and abdominal pain. Probiotics supplementation is defined as the adding of non-pathologic living microorgnisms. Numerous recent studies including meta-analyses and several randomized control trials revealed supplementary probiotics may improve the adverse effects and increase the successful rate of eradication therapy. Therefore, this study aim to assess the clinical impact of probiotics on Bismuth therapy and eradication of H. pylori. It's a multicentered, randomized double blind placebo-controlled trial to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication. During the study, expected 200 patients failing in first-line Bismuth therapy would be enrolled in the trial. 200 patients are divided into two groups: one group receive probiotic for treatment period and the other group receive placebo. The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and probiotic (or placebo) is taken from day 1~56. There are 5 visits for subjects to follow: day 0, day 10, day 56, 1 year and 3 years(optional). Esophagogastroduodenal scope for the pathology, H. pylori culture, susceptibility testing, genotypic resistance and virulence factors before D0. 13C-Urea breath tests are used to check Helicobacter pylori eradication on day 56, 1 year and 3 year. In addition to blood samples for general tests, stool samples would be collected on every visit to analyze gut microbiota.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H.Pylori Gastrointestinal Disease
Keywords
supplementary pylori, Bismuth quadruple therapy, H. pylori eradication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
200 patients are divided into two groups: one group receive probiotic for treatment period and the other group receive placebo. The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and probiotic (or placebo) is taken from day 1~56.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics packets
Arm Type
Experimental
Arm Description
Probiotics contains 450 billion colony-forming units per packet. The compositions are maltose, lactic acid bacteria and bifidobacteria blend, cornstarch, silicon dioxide.
Arm Title
Placebo packets
Arm Type
Placebo Comparator
Arm Description
The compositions are maltodextrin, silicon dioxide, sucralose
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics packets
Intervention Description
The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and Probiotics packets is taken from day 1~56.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo packets
Intervention Description
The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and Placebo packets is taken from day 1~56.
Primary Outcome Measure Information:
Title
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Description
Adverse events are collected
Time Frame
From Day 0 to Day 10.
Title
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Description
Adverse events are collected
Time Frame
From Day 0 to Day 56.
Secondary Outcome Measure Information:
Title
Eradication rate of second line BQT between two groups
Description
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Time Frame
From Day 0 to Day 56.
Title
Dynamic changes in the gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
Day 0.
Title
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
Day 0.
Title
Re-infection rate 1 year and 3 years after second line eradication therapy
Description
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Time Frame
From Day 0 to Day 56.
Title
Changes in the parameters of metabolic syndrome between two groups
Description
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Time Frame
Day 0.
Title
Eradication rate of second line BQT between two groups
Description
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Time Frame
From Day 0 to 1 year.
Title
Eradication rate of second line BQT between two groups
Description
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Time Frame
From Day 0 to 3 years.
Title
Dynamic changes in the gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
Day 10.
Title
Dynamic changes in the gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
Day 56.
Title
Dynamic changes in the gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
1 year.
Title
Dynamic changes in the gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
3 years.
Title
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
Day 10.
Title
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
Day 56 .
Title
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
1 year .
Title
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Description
Stool sample collection for gut microbiota analysis
Time Frame
3 years.
Title
Re-infection rate 1 year and 3 years after second line eradication therapy
Description
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Time Frame
From Day 0 to 1 year.
Title
Re-infection rate 1 year and 3 years after second line eradication therapy
Description
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Time Frame
From Day 0 to 3 years.
Title
Changes in the parameters of metabolic syndrome between two groups
Description
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Time Frame
Day 56.
Title
Changes in the parameters of metabolic syndrome between two groups
Description
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Time Frame
1 year.
Title
Changes in the parameters of metabolic syndrome between two groups
Description
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Time Frame
3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 20 years-old underwent documented non-Bismuth containing 1st line H. pylori eradication with failure defined by positive 13C-Urea Breath Test (13C-UBT) at least 6 weeks after completion of therapy is eligible to the study. Exclusion Criteria: History of gastrectomy, surgery in the small intestine or colon History of gastric malignancy, including adenocarcinoma or lymphoma Allergic history, history of severe adverse effects or contraindication to antibiotics (Tetracycline, Metronidazole ), proton pump inhibitor, or probiotics Pregnant or lactating women Severe concurrent chronic or acute disease (e.g. renal failure, liver cirrhosis, or active malignancy) Concomitant use of clopidogrel or warfarin Recent (<4 weeks) use of antibiotics, or recent (<4 weeks) probiotic use duration >2 weeks Not able to give consent on blinding or randomizatio Not able to give consent by his or herself
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyh-Ming Liou, doctor
Phone
+886-972-651883
Email
nneder34@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Lun Han, doctor
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Yunlin Branch
City
Douliu
ZIP/Postal Code
64041
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Jen Fang, Doctor
Phone
+886-972-655374
Email
toby851072@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Yu-Jen Fang
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JHENG-YI WU
Phone
+886-988-358359
Email
joywu@kmu.edu.tw
First Name & Middle Initial & Last Name & Degree
JHENG-YI WU
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100225
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyh-Ming Liou, doctor
Phone
+886-972-651883
Email
nneder34@gmail.com
First Name & Middle Initial & Last Name & Degree
Ming-Lun Han
Facility Name
National Taiwan University Cancer Center
City
Taipei
ZIP/Postal Code
10672
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyh-Ming Liou, Doctor
First Name & Middle Initial & Last Name & Degree
Jyh-Ming Liou
Phone
+886-972-651883
Email
nneder34@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

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