Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection

NCT01906879 | Unknown Phase 4 DMC

• 1 other identifier: 201304017MINB
• Study Type: interventional
• Target: 1,620
• Locations: 1 country
• Sites: 10

Brief Summary

Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown. Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days. Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy Testing for H. pylori infection Before First Line Ttreatment (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication rate for H. pylori

  Eradication rate in the first line according to intention to treat (ITT) and per-protocol (PP) analysis in the three treatment groups

  6 weeks

Secondary Outcomes (1)

• Adverse effects of each treatments

  2 weeks

Other Outcomes (1)

• Reinfection rate

  1 year

Study Arms (3)

Triple therapy (A)

ACTIVE COMPARATOR

lansoprazole, 30mg, twice daily, for 14 days, po clarithromycin, 500mg, twice daily, for 14 days, po amoxicillin, 1gm, twice daily, for 14 days, po

Drug: triple, quadruple, non-bismuth quadruple therapy

non-bismuth quadruple therapy

EXPERIMENTAL

Group (B): non-bismuth quadruple therapy for 10 days: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid

Drug: triple, quadruple, non-bismuth quadruple therapy

bismuth quadruple therapy for 10 days

EXPERIMENTAL

Group (C): bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid

Drug: triple, quadruple, non-bismuth quadruple therapy

Interventions

triple, quadruple, non-bismuth quadruple therapy DRUG

triple therapy, quadruple therapy, non-bismuth quadruple therapy

Also known as: Group (A): triple therapy for 14 days, Group (B): non-bismuth quadruple therapy for 10 days, Group (C): bismuth quadruple therapy for 10 days

Triple therapy (A); bismuth quadruple therapy for 10 days; non-bismuth quadruple therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrolment. Written informed consents will be obtained from all patients prior to enrollment.

You may not qualify if:

• Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, or levofloxacin) and prompt pump inhibitors (lansoprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent diseases, and (8) Patients who cannot give informed consent by himself or herself.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (10)

Chiayi Christian Hospital

Chiayi City, Taiwan

RECRUITING

National Taiwan University Hospital, Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

E- DA Hospital and I-Shou University

Kaohsiung City, Taiwan

RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

Ming-Shiang Wu

Taipei, 10002, Taiwan

RECRUITING

Mackay Memorial Hospital, Taipei

Taipei, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Mackay Memorial Hospital, Taitung

Taitung, Taiwan

RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Yun-Lin County, Taiwan

RECRUITING

Related Publications (2)

• Liou JM, Chen CC, Chang CM, Fang YJ, Bair MJ, Chen PY, Chang CY, Hsu YC, Chen MJ, Chen CC, Lee JY, Yang TH, Luo JC, Chen CY, Hsu WF, Chen YN, Wu JY, Lin JT, Lu TP, Chuang EY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Long-term changes of gut microbiota, antibiotic resistance, and metabolic parameters after Helicobacter pylori eradication: a multicentre, open-label, randomised trial. Lancet Infect Dis. 2019 Oct;19(10):1109-1120. doi: 10.1016/S1473-3099(19)30272-5.

  PMID: 31559966 DERIVED

• Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.

  PMID: 27769562 DERIVED

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Ming-Shiang Wu, MD. PhD

  National Taiwan University Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyh-Ming Liou, MD, PhD

CONTACT

dtmed046@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2013
• First Posted: July 24, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

TW (10)