The Effects of Synbiotic " B94 plus Inulin" Addition on Standard Triple Therapy of Eradication in Children.

Aim: The aim of this study is to evaluate the effects of the synbiotic B94 plus inulin addition to the standard triple therapy on infection eradication rates.

Methods: Children aged 6-16 years who had biopsy proven infection were randomly classified into two groups. The first group received the standard triple therapy consisting of amoxicillin + clarithromycin + omeprazole. The second group was treated with the standard triple therapy and B94 (5 × 10 CFU/dose) plus inulin (900 mg) for 14 days, concurrently. Eradication was determined by C-urea breath test 4-6 weeks after therapy discontinuation.

Results: From a total of 69 infected children (F/M = 36/33; mean ± SD = 11.2 ± 3.0 years), eradication was achieved in 20/34 participants in the standard therapy group and 27/35 participants in the synbiotic group. The eradication rates were not significantly different between the standard therapy and the synbiotic groups [intent-to-treat, 58.8% and 77.1%, resp., = 0.16; per-protocol, 64.5% and 81.8%, resp., = 0.19]. There was no difference between the groups in terms of symptom relief ( = 0.193). The reported side effects were ignorable.

Conclusion: Considering the eradication rates, synbiotic addition to therapy showed no superiority over the standard triple therapy conducted alone. This trial is registered with NCT03165253.