Skip to main content
OpenTrials
Completed

NCT Number: NCT01481844

Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Optimization of Second Line Treatment Protocol for H Pylori Eradication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soroca UMC

Beersheba, Israel

About this study

a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up.

Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group.

The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication.

Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects.

Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent
  • age at least 18 years
  • persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)

Exclusion criteria

  • history of gastrectomy
  • gastric malignancy, including adenocarcinoma and lymphoma
  • previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors
  • Active upper gastrointestinal bleeding within the previous 1 week
  • contraindications to the treatment drugs
  • Pregnant or lactating women
  • Severe concurrent disease or malignancy

Treatment and study plan

Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole

Drug

use of Sequential therapy as second line treatment for eradication H pylori currently Sequential therapy is indicated as first line treatment for H pylori eradication

Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline

Drug

this combination is standard of care as H pylori second line treatment

Primary outcomes

  1. The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen

    Time frame: 18 month

    H pylori eradication is defined as a negative C-urea breath test 4-16 weeks after completion of tratment.]. (C-urea breath test- Patients are fasted for 4 h before testing. No test meal will be given, and a pre-dose breath sample is obtained. 75 mg of 13C-urea powder dissolved in 50 mL of water is then administered orally, and a second breath sample is collected 30 minutes later. Collected samples are analyzed using an isotope ratio mass spectrometer).

Secondary outcomes

  1. The secondary end points: Adverse effects of sequential and quadruple treatment

    Time frame: 18 months

    -Adverse effects -taste alteration , peripheral neuropathy, seizures, nausea, vomiting, diarrhea, abdominal pain, allergic reaction, photo sensibility-checked at clinical visit by direct question.

  2. compliance with treatment

    Time frame: 18 months

    compliance is considered to be satisfactory when drug intake exceeded 80 %( by pills count).

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 30, 2011
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.