Track topics on Twitter Track topics that are important to you
Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country.
The aims of this study are:
1. to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;
2. to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy as rescue regimen in H. pylori eradication;
3. to compare the patient adherence and adverse effects of these treatment regimens;
4. to investigate factors that may influence H. pylori eradication by these treatment regimens;
5. to investigate and analyze the prevalence and trend of antibiotic resistance.
Patients having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the 13C-urea breath test if the patients refuse the second endoscopy. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into three subgroups, say A1, B1 and C1 (or A2, B2, and C2).
If the patients did not receive anti-H. pylori therapy previously, they will be invited to enter the first part of study for evaluating the efficacy of 1st-line regimens. If the patients had received anti-H. pylori therapy previously, they will be invited to enter the second part of study for evaluating the efficacy of rescue regimens. Patients who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:
- for 1st-line regimens: group A1 - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B1 - sequential therapy (rabeprazole 20 mg + amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for next 5 days); group C1 - clarithromycin-based triple therapy (rabeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg, bid for 7 days).
- for rescue regimens: group A2 - high dose dual therapy (as group A1); group B2 - sequential therapy (as group B1); group C2 - levofloxacin-based triple therapy (rabeprazole 20 mg + amoxicillin 1000 mg + levofloxacin 250 mg, bid for 7 days).
All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the patients were seen at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
high dose dual therapy, sequential therapy, clarithromycin-based triple therapy, levofloxacin-based triple therapy
National Taiwan University Hospital
Not yet recruiting
National Taiwan University Hospital
Published on BioPortfolio: 2014-07-23T21:08:07-0400
Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurenc...
Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.
Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the...
To assess if a sequential treatment regimen better eradicates H. pylori than does a triple drug regimen in adults with dyspepsia or peptic ulcer disease.
The Asian-Pacific Consensus Report has recommended that proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for ...
Clarithromycin (CAM)-based triple therapy comprising proton pump inhibitors and amoxicillin is administered as first-line eradication treatment against Helicobacter pylori infection. However, the erad...
Italian guideline suggests 10-day sequential or bismuth-based quadruple therapies for first-line Helicobacter pylori treatment. Comparison between these regimens is lacking. We assessed the efficacy o...
The number of patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) is increasing. Since these patients have a CHADS-VASc score of 1 or higher, they should be treated w...
The DOLULAM study assessed the efficacy of dolutegravir + lamivudine dual therapy to maintain virological suppression in heavily treatment-experienced HIV-1-infected adults. No virological failure...
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.
The treatment of immune system diseases by deliberate infestation with helminths. This therapy is partly based on the HYGIENE HYPOTHESIS which states that the absence of parasites increases immune dysregulation because of the lack of stimulation of REGULATORY T-CELLS.
A therapeutic approach, involving chemotherapy, radiation therapy, or surgery, after initial regimens have failed to lead to improvement in a patient's condition. Salvage therapy is most often used for neoplastic diseases.
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Peptic Ulcer Disease
Peptic Ulcer Disease - stomach ulcer, duodenal ulcers used to refer to all types of peptic ulcers. A peptic ulcer is an erosion in a segment of the Gastrointestinal (GI) muscularis mucosae, typically in the stomach (gastric ulcer) or the first few cent...
MRSA (methicillin-resistant Staphylococcus aureus)
MRSA (methicillin-resistant Staphylococcus aureus) is a family of bacteria with resistance to one or more major antibiotics. There are currently 17 different strains of MRSA. Two particular strains, EMRSA15 and EMRSA16 account for 96% of MRSA blood...