Assessment of Efficacy and Adverse Effects of Bismuth-Based Treatment Combined with Bifidobacterium Lactis for Eradication of Helicobacter Pylori in Turkish Children

Objective There are many adverse effects of drugs used to eradicate Helicobacter pylori, and reconstructing the microbiota by external ingestion of probiotics seems to have good effects on H. pylori eradication and prevents side effects. Methods The study included 161 outpatients aged between 8 and 18 years diagnosed with H. pylori gastritis in the Gülhane Training and Research Hospital Pediatric Gastroenterology unit from June 1, 2018, through March 31, 2020, and patients were randomized into two groups. Eighty patients in the probiotic group (first group) received H. pylori eradication therapy for 14 days; additionally, Bifidobacterium lactis B94 was administered for 14 days for eradication of H. pylori. Eighty-one patients in the standard therapy group (second group) received the same eradication therapy but no probiotics. All patients were asked to complete a detailed questionnaire regularly, including changes in symptoms and side effects of drugs on days 0, 7, and 14 of treatment. The eradication success was checked with the H. pylori stool antigen test kit 8 weeks after completion of the treatment regimen. Results The mean age of the patients was 14.2 ± 2.9 years, and 88 (64.7%) were female. The eradication rates were similar between the standard therapy and the probiotic groups by intention-to-treat analysis (p = 0.930). In order of frequency, the most common eradication treatment–related side effects were abdominal pain, taste abnormalities, and anorexia. In addition, therapy-related epigastric pain and flatulence were similar initially (p > 0.05) but seemed to be significantly lower in the probiotic group than in the standard therapy group on days 7 and 14 (p < 0.05). Conclusions Our results suggest that additional probiotic supplementation has not changed the eradication rates but seems to reduce some specific gastrointestinal adverse events in children with H. pylori infections treated with a bismuth-based quadruple eradication regimen. More extensive randomized controlled trials are needed to explain probiotics' effects on H. pylori eradication and drug side effects.