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IRCT201209041579N4 IRCT 2012-10-03 Vice Chancellor for Research, Isfahan University of Medical Sciences Probiotic for eradication of helicobacter pylori Evaluating the effects of adding the probiotic Balance® compared with placebo to quadruple therapy on eradication of helicobacter pylori and symptoms of patients with peptic ulcer disease referring to gastroenterology clinics in Isfahan 2011-07-23 anticipated 180 Complete https://irct.ir/trial/987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were randomly assigned to two groups according to a table of random numbers created by the software. Placebo capsule was the same as Balance® capsule and both the physician and the patient were unaware about the treatment arms. 2-3 Helicobacter pylori infection. Intervention 1: Intervention group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, Iran) twice daily, Amoxicillin 1 gr (Farabi Co., Tehran, Iran) twice daily, and Clarithromycin 500 mg (Loghman Co., Tehran, Iran) twice daily for 14 days. Plus - Capsules of Balance® (Protexin Co., Somerset, UK) twice daily for 14 days. Each capsule of Balance® contains: Lactobacillus casei PXN 37 Lactobacillus rhamnosus PXN 54 Streptococcus thermophilus PXN 66 Bifidobacterium breve PXN 25 Lactobacillus acidophilus PXN 35 Bifidobacterium longum PXN 30 Lactobacillus bulgaricus PXN 39. TVC per capsule: 100 million CFU. Intervention 2: Control group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, Iran) twice daily, Amoxicillin 1 gr (Farabi Co., Tehran, Iran) twice daily, and Clarithromycin 500 mg (Loghman Co., Tehran, Iran) twice daily for 14 days. Plus - Capsules of placebo twice daily for 14 days. http://onlinelibrary.wiley.com/doi/10.1111/hel.12047/abstract BACKGROUND:<br /> <br /> Evidence has shown benefits of single-strain probiotics for Helicobacter pylori eradication. We investigated the effects of adding a multistrain probiotic compound on bismuth-containing quadruple therapy for H. pylori infection.<br /> MATERIALS AND METHODS:<br /> <br /> Adult patients with peptic ulcer disease and confirmed H. pylori infection (n = 180) were randomized to receive bismuth-containing quadruple therapy (omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin) plus a probiotic compound or placebo for 2 weeks. The probiotic compound contained seven bacterial species including Lactobacillus and Bifidobacterium strains and Streptococcus thermophiles. Eradication of H. pylori was assessed 4 weeks after medication by (13) C urea breath test. Other outcomes were dyspepsia symptoms, therapy-related adverse effects, and patient's tolerance.<br /> RESULTS:<br /> <br /> Eighty-four patients in the probiotic and 86 in the placebo group completed the trial. With per-protocol (intention to treat) analysis, H. pylori was eradicated in 82.1% (76.6%) of the probiotic and 84.8% (81.1%) of the placebo group, p = .392 (0.292). Symptoms were significantly improved with similar trends in both groups. Regarding the adverse effects, diarrhea was less frequent (2.2 vs 11.1%, p = .016), while abdominal pain was more frequent (10 vs 2.2%, p = .029) in the probiotic group. The two groups were similar in treatment tolerance (p = .851).<br /> CONCLUSIONS:<br /> <br /> In overall, our studied multistrain probiotic compound has not beneficial effects in the treatment of H. pylori infection. It might be related to the low dosage of our probiotic regimen and/or high frequency of upper gastrointestinal adverse effects which in turn could decrease the eradication efficacy.
public Dr. Elham Tabesh
Internal Medicine Group, Isfahan University of Medical Sciences, Hezar Jarib Street
Isfahan Iran (Islamic Republic of) +98 31 1792 2472 elham7979@yahoo.com Isfahan University of Medical Sciences scientific Dr. Ahmad Shavakhi
Internal Medicine Group, Isfahan University of Medical Sciences, Hezar Jarib Street
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 1792 2472 shavakhi@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: - Age 18 to 65 years, - Having peptic ulcer disease on upper gastrointestinal endoscopy, - Having helicobacter pylori infection diagnosed by rapid urease test or urea breath test, - Willingness to participate in the study, - Not having Zollinger Ellison Syndrome, cancers of the digestive tract, liver or kidney diseases, other infections may require antibiotics, immune deficiency disease, - No history of upper gastrointestinal surgery, - No history of the eradication of Helicobacter pylori, or the use of Proton Pomp Inhibitors, antibiotics, and probiotics (synthetic or natural) over the past 4 weeks, - No contraindications for using any dug of the quadruple therapy. Exclusion criteria: - Not taking medications regularly, (not taking >= 20% of all the prescribed capsules), - Severe side effects of the quadruple therapy. 18 years 65 years Both B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified Treatment - Drugs Placebo Intervention group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, Iran) twice daily, Amoxicillin 1 gr (Farabi Co., Tehran, Iran) twice daily, and Clarithromycin 500 mg (Loghman Co., Tehran, Iran) twice daily for 14 days. Plus - Capsules of Balance® (Protexin Co., Somerset, UK) twice daily for 14 days. Each capsule of Balance® contains: Lactobacillus casei PXN 37 Lactobacillus rhamnosus PXN 54 Streptococcus thermophilus PXN 66 Bifidobacterium breve PXN 25 Lactobacillus acidophilus PXN 35 Bifidobacterium longum PXN 30 Lactobacillus bulgaricus PXN 39. TVC per capsule: 100 million CFU Control group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, Iran) twice daily, Amoxicillin 1 gr (Farabi Co., Tehran, Iran) twice daily, and Clarithromycin 500 mg (Loghman Co., Tehran, Iran) twice daily for 14 days. Plus - Capsules of placebo twice daily for 14 days Helicobacter pylori eradication. Timepoint: Four weeks after treatment. Method of measurement: Urea breath test. Dyspepsia symptoms severity. Timepoint: At baseline, 15th day, and 4 weeks after treatment. Method of measurement: Lead Dyspepsia Questionnaire. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2011-07-10 The Ethics Committee of Isfahan University of Medical Sciences Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jarib Street Isfahan Iran (Islamic Republic of)