helicobacter eradication relief of dyspeptic symptoms

Conditions: Functional Dyspepsia

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

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

Eligibility criteria:
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

Keywords: functional dyspepsia helicobacter pylori anti-inflammatory agents, non-steroidal gastritis