Skip to content

Effectiveness of 7-day and 14-day high-dose PPI bismuth-containing quadruple therapy with probiotics supplement for Helicobacter pylori eradication: A double blinded-randomized placebo-controlled study

Effectiveness of 7-day and 14-day high-dose PPI bismuth-containing quadruple therapy with probiotics supplement for Helicobacter pylori eradication: A double blinded-randomized placebo-controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190127003
Enrollment
Unknown
Registered
2019-01-27
Start date
2018-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effectiveness of 7&#45

Interventions

60 mg dexlansoprazole twice daily 1048 mg bismuth subsalicylate twice daily 500 mg tetracycline four times daily and 400 mg metronidazole three times daily Probiotic was 37.5 mg Lactobacillus reuter
Active Comparator Drug,Active Comparator Drug
7&#45
day high&#45
dose PPI bismuth&#45
containing quadruple therapy ,14&#45
containing quadruple therapy

Sponsors

Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Having abdominal pain which was indicative for assessing with esophagogastroduodenoscopy consistent with The Gastroenterological Association of Thailand(12) as followed; • Coexisting with dysphagia • Evidence of gastrointestinal blood loss such as previous history of bloody vomiting, melena and iron deficiency anemia • Unexplained weight loss such as unintended weight losing, recent diagnosis of diabetes mellitus or thyrotoxicosis • Persistent vomiting • Age onset of symptoms > 50 years old without any explainable causes including drugs and food • Progressive or recurrent symptoms after adequate medical treatments 2. Detecting for H. pylori infection with positive urease test and/or pathological findings of H. pylori and/or positive cultures 3. Having written informed consent for all participants.

Exclusion criteria

Exclusion criteria: 1. Any cases with upper gastrointestinal bleeding 2. Being treated with medications affecting the research outcome&#44; for example&#44; by using antibiotics including amoxicillin&#44; clarithromycin&#44; tetracycline or metronidazole within 1 month before the enrollment 3. Having contraindication to gastric biopsy such as coagulopathy 4. Any history of drug allergy for Tetracycline&#44; Metronidazole&#44; Bismuth&#44; and Dexlansoprazole 5. Receiving proton pump inhibitor or receiving any antibiotics or bismuth within 4 weeks or consumption of probiotic products within 2 weeks. 6. Being pregnant or raising children with breast&#45;feeding 7. Having history of H. pylori eradication treatment 8. Having severe underlying disease including end&#45;stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15)&#44; cirrhosis with Child&#45;Pugh classification grade C&#44; immunocompromised host with AIDS&#44; malignancy and/or bed ridden cerebrovascular disease. 9. Any cases who receiving anticoagulant 10. Having previous gastric surgery 11. Unwilling to participate into research 12. Having history of taking previous medications which interacted with the research treatment 13. Having a medication that causes drugs to drugs interaction with a research medication

Design outcomes

Primary

MeasureTime frame
Effecitveness 4 weeks after intervention Helicobacter pylori eradication

Secondary

MeasureTime frame
Compare effectiveness of Helicobacter Pylori eradication 4 weeks after intervention Helicobacter pylori eradication

Contacts

Public ContactPiyakorn Poonyam

Thammasat University

piyakorn@g.swu.ac.th+66 861296573

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026