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.