Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.
The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.
From the Department of Gastroenterology, Clinical Hospital Centre, Rijeka, Rijeka, Croatia (GH, DS); Department of Gastroenterology and Hepatology, University Clinical Centre, Tuzla, Tuzla, Bosnia and Herzegovina (NS); and JGL d.d. Rijeka, Croatia (KV, AJ).
Goran
G
Hauser
Nermin
N
Salkic
Karina
K
Vukelic
Alenka
A
JajacKnez
Davor
D
Stimac
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use; D017963:Azithromycin / Q000627:therapeutic use; D001644:Bifidobacterium; D017291:Clarithromycin / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D052201:Lacticaseibacillus rhamnosus; D064747:Lansoprazole / Q000627:therapeutic use; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D000077402:Pantoprazole; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D010919:Placebos; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017963:Azithromycin; D000077402:Pantoprazole; D017291:Clarithromycin; D009853:Omeprazole