Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-29

Study Completion Date

2025-04-29

Brief Summary

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This study is designed to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication

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Detailed Description

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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.

Conditions

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H.Pylori Gastrointestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics packets

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

Group Type EXPERIMENTAL

Probiotics packets

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo packets

The compositions are maltodextrin, silicon dioxide, sucralose

Group Type PLACEBO_COMPARATOR

Placebo packets

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Probiotics packets

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

Placebo packets

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No