UnknownNot Applicable

Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

Taiwan200 participantsStarted 2021-08-29

Plain-language summary

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

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 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.

Timeframe: From Day 0 to Day 56.

Trial details

NCT IDNCT05577572

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-29

Contact for this trial

Jyh-Ming Liou, doctor

+886-972-651883 nneder34@gmail.com

View on ClinicalTrials.gov More H.Pylori Gastrointestinal Disease trials

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 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.

Timeframe: From Day 0 to Day 56.