Helicobacter Eradication Relief of Dyspeptic Symptoms

Study Overview
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Brief Summary
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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
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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

Official Title
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Dyspeptic Symptoms Evolution After Eradication of Helicobacter Pylori in Patients With Different Endoscopic Findings: a Randomized Double-blind Placebo-controlled Clinical Trial With 12 Months of Follow-up

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days | Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days<br>* Amoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days.<br>|
| Placebo Comparator: 2<br>Placebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days | Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days<br>* Amoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Lost of productivity measured by WPAI between groups |  | 12 months | 
| Adverse Events |  | 4 , 8 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, Helicobacter pylori, Anti-Inflammatory Agents, Non-Steroidal, Gastritis