The study was performed at Children's Medical Center in Tehran, Iran, from November 2011 to April 2012. In a randomized double blind clinical trial, sixty six children aged 3-14 years with H. Pylori infection enrolled in this study. The patients were referred to gastroenterology clinic for the evaluation of symptoms and signs including chronic abdominal pain, gastrointestinal bleeding, unexplained frequent vomiting and unexplained iron deficiency anemia.
Inclusion criterion was the presence of H. pylori infection. Exclusion criteria were as follows: 1) consumption of PPIs, H2 receptor antagonists, bismuth compounds and antibiotics in the previous 2 weeks, 2) previous gastric surgery, 3) known allergy to certain antibiotics, 4)glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency (furazolidone may cause hemolysis and anemia in these deficient patients), and 5) known previous history of renal failure and endocrine, cardiac, or hepatic disease.
Ethics: The research protocol was approved by the medical ethic committee of Tehran University of Medical Sciences and allocated an ethical code. Registration ID of this study in Iranian Registry of Clinical Trials was IRCT201201218793N1. Informed consent was obtained from parents of all patients.
All patients were included for esophagogastroduodenoscopy. H. pylori infection was established by at least one of these criteria: A positive rapid urease test (RUT) or histopathological examination. Upper gastrointestinal endoscopy was carried out after midazolam sedation (0.1 mg/kg). Two pieces of gastric antral biopsy specimens were taken for histology and RUT. Patients were randomly assigned following simple randomization procedures to one of two treatment groups (A: antibiotic+PPI+placebo, B: antibiotic+PPI+ probiotic). Label of drugs was replaced by a new one indicating drug A or B. Contents of sachets were not known to the physician, research fellow, and nurses involved in recording data. All H. pylori positive children in group A were treated with a one-week course of amoxicillin (50 mg/kg/day bid as syrup or capsule) and furazolidone (6 mg/kg/day bid as syrup or tablet), four weeks of omeprazole (1mg/kg/day) plus placebo. Group B received the same antibiotics and PPI plus probiotic preparation 1 sachet/day (restore, 1×109 CFU/1 sachet, Protexin Co, UK). Probiotic combination consisted of strains of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium infantis and Bifidobacterium breve ().
Flow diagram of randomization, allocation, follow-up and analysis
Study design: After endoscopic evaluation and randomization the treatment was started. During the course of treatment and at follow-up, patients were contacted by phone and were asked about the side effects of therapy on a weekly basis. The side effects included diarrhea, nausea/vomiting and abdominal bloating. They had a visit as an outpatient at the middle of therapeutic course. All patients were reinvestigated four to eight weeks after accomplished treatment by stool antigen test for H. pylori. Successful treatment was defined as a negative stool antigen test for H. pylori.
Outcome parameters: Primary outcome measure was the rate of eradication of H. pylori defined as a negative stool antigen test. Secondary outcomes were the rate of side effects during the treatment reported by the patients or parents.
Statistical analysis: The SPSS software version 18 (SPSS Inc., Chicago, IL, USA) was used to appraise the statistical analysis; statistical analytical tests Chi-square or Fisher's exact test and Logistic Regression were used for analyzing data. A P-value of less than 0.05 was considered significant.