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

Not Applicable

Recruiting

• Conditions: Effectiveness of 7- day and 14- day high- dose PPI bismuth- containing quadruple therapy with probiotics supplement for Helicobacter pylori eradication

• Registration Number: TCTR20190127003
• Lead Sponsor: Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-27
• Study Completion: 2019-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

1.Any cases with upper gastrointestinal bleeding
2.Being treated with medications affecting the research outcome, for example, by using antibiotics including amoxicillin, clarithromycin, 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, Metronidazole, Bismuth, 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-feeding
7.Having history of H. pylori eradication treatment
8.Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pugh classification grade C, immunocompromised host with AIDS, 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effecitveness 4 weeks after intervention Helicobacter pylori eradication

Secondary Outcome Measures

Name	Time	Method
Compare effectiveness of Helicobacter Pylori eradication 4 weeks after intervention Helicobacter pylori eradication