Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

Not Applicable

Recruiting

• Conditions: H.Pylori Gastrointestinal Disease
• Interventions: Dietary Supplement: Placebo packets; Dietary Supplement: Probiotics packets

• Registration Number: NCT05577572
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-06-14
• Study Start: 2021-08-29
• Status Verified: 2022-09
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21
• Primary Completion: 2023-04-29
• Study Completion: 2025-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo packets	Placebo packets	The compositions are maltodextrin, silicon dioxide, sucralose
Probiotics packets	Probiotics packets	Probiotics contains 450 billion colony-forming units per packet. The compositions are maltose, lactic acid bacteria and bifidobacteria blend, cornstarch, silicon dioxide.

Primary Outcome Measures

Name	Time	Method
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.	From Day 0 to Day 56.	Adverse events are collected

Secondary Outcome Measures

Name	Time	Method
Re-infection rate 1 year and 3 years after second line eradication therapy	From Day 0 to 3 years.	13C-Urea breath tests are performed to check the Helicobacter pylori infection
Dynamic changes in the gut microbiota between two groups	3 years.	Stool sample collection for gut microbiota analysis
Changes in the parameters of metabolic syndrome between two groups	3 years.	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.
Dynamic changes in the metabolic pathway of gut microbiota between two groups	3 years.	Stool sample collection for gut microbiota analysis
Eradication rate of second line BQT between two groups	From Day 0 to 3 years.	13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups

Trial Locations

Locations (4)

National Taiwan University Hospital Yunlin Branch; 🇨🇳 Douliu, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan