NCT05577572

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 29, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
Last Updated

October 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

June 14, 2021

Last Update Submit

October 19, 2022

Conditions

H.Pylori Gastrointestinal Disease

Keywords

supplementary pyloriBismuth quadruple therapyH. pylori eradication

Outcome Measures

Primary Outcomes (2)

  • 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

    From Day 0 to Day 10.

  • 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

    From Day 0 to Day 56.

Secondary Outcomes (20)

  • Eradication rate of second line BQT between two groups

    From Day 0 to Day 56.

  • Dynamic changes in the gut microbiota between two groups

    Day 0.

  • Dynamic changes in the metabolic pathway of gut microbiota between two groups

    Day 0.

  • Re-infection rate 1 year and 3 years after second line eradication therapy

    From Day 0 to Day 56.

  • Changes in the parameters of metabolic syndrome between two groups

    Day 0.

  • +15 more secondary outcomes

Study Arms (2)

Probiotics packets

EXPERIMENTAL

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

Dietary Supplement: Probiotics packets

Placebo packets

PLACEBO COMPARATOR

The compositions are maltodextrin, silicon dioxide, sucralose

Dietary Supplement: Placebo packets

Interventions

Probiotics packetsDIETARY_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.

Probiotics packets
Placebo packetsDIETARY_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.

Placebo packets

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Taiwan University Hospital Yunlin Branch

Douliu, 64041, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, 10672, Taiwan

RECRUITING

Study Officials

  • Ming-Lun Han, doctor

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyh-Ming Liou, doctor

CONTACT

+886-972-651883nneder34@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

October 13, 2022

Study Start

August 29, 2021

Primary Completion

April 29, 2023

Study Completion

April 29, 2025

Last Updated

October 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(4)