Helicobacter Eradication Relief of Dyspeptic Symptoms
- Conditions
- Functional Dyspepsia
- Interventions
- Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days
- Registration Number
- NCT00404534
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
- Detailed Description
Objective: investigate if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradication than the placebo control group
Design: A randomized double-blind placebo controlled clinical trial
Inclusion Criteria: Patients with more than 18 years, Functional dyspepsia accordingly Rome III criteria, Helicobacter pylori infection by two diagnostic tests
Exclusion Criteria: No concordance with informed consent; Pregnant woman or breast feeding or no trust anticonceptional method; Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia; Previous treatment for Helicobacter pylori infection; Previous surgery on esophagus, stomach or duodenum; Hypersensitivity to the drugs in study; Proton pump inhibitor use in the previous 15 days; H2-antagonists use in the previous 07 days; Antibiotics use in the previous 30 days; Patients unable to answer the study questionnaires; Alcohol abuse; Drug use; Serious comorbidities; Biliary colic; Irritable bowel syndrome; Gastroesophageal Reflux Disease
Interventions: amoxicillin, clarythromycin, omeprazole for 10 days
Control: Placebo
Outcomes:
Primary: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire Secondary: Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire; Need of rescue medication; Median difference of score between groups; Mean SF-36 scores evolution between groups; Lost of productivity measured by WPAI between groups
Visits: screening, baseline, 4, 8, 12 months
Endoscopic evaluation: screening, 12 months
Helicobacter detection methods: urease, histology (3 pathologists) performed at screening and 12 months
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
- Patients with more than 18 years
- Functional dyspepsia accordingly Rome III criteria
- Helicobacter pylori infection by two diagnostic tests
- No concordance with informed consent
- Pregnant woman or breast feeding or no trust anticonceptional method
- Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia
- Previous treatment for Helicobacter pylori infection
- Previous surgery on esophagus, stomach or duodenum
- Hypersensitivity to the drugs in study
- Proton pump inhibitor use in the previous 15 days
- H2-antagonists use in the previous 07 days
- Antibiotics use in the previous 30 days
- Patients unable to answer the study questionnaires
- Alcohol abuse
- Drug use
- Serious comorbidities
- Biliary colic
- Irritable bowel syndrome
- Gastroesophageal Reflux Disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Amoxicillin, Clarythromycin, Omeprazole for ten days Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days 2 Amoxicillin, Clarythromycin, Omeprazole for ten days Placebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days
- Primary Outcome Measures
Name Time Method Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire the last visit among the antecipated visits (4, 8 and 12 months)
- Secondary Outcome Measures
Name Time Method Lost of productivity measured by WPAI between groups 12 months Adverse Events 4 , 8 and 12 months Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire the last visit among the antecipated visits (4, 8 and 12 months) Need of rescue medication 4, 8 and 12 months Median difference of score between groups the last visit among the antecipated visits (4, 8 and 12 months) Mean SF-36 scores evolution between groups 12 months
Trial Locations
- Locations (1)
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil