Helicobacter Eradication Relief of Dyspeptic Symptoms

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

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