Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

Last updated: October 19, 2022
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcers

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT05577572
201912191MIPC
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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, oractive malignancy)
  6. Concomitant use of clopidogrel or warfarin
  7. Recent (<4 weeks) use of antibiotics, or recent (<4 weeks) probiotic use duration >2weeks
  8. Not able to give consent on blinding or randomizatio
  9. Not able to give consent by his or herself

Study Design

Total Participants: 200
Study Start date:
August 29, 2021
Estimated Completion Date:
April 29, 2025

Study 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 110 and probiotic (or placebo) is taken from day 156.

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.

Connect with a study center

  • National Taiwan University Hospital Yunlin Branch

    Douliu, 64041
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • National Taiwan University Cancer Center

    Taipei, 10672
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100225
    Taiwan

    Active - Recruiting

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