It is well known that childhood is an important period for acquisition of H.P. infection. Intrafamiliar trasmission of the infection , especially from mother to child, has been hypothisized as the major mode of dissemination
. H.P. is considered to be the major cause of chronic gastritis and duodenal ulcer in childhood and an important cofactor in the development of gastric cancer
. Unfortunately eradication therapy is not always successful and reports of failed H.P. eradication therapy are increasing. Therefore, recent review studies report eradication rates of standard triple therapy in children below 75%
[14, 19]. Moreover this regimens have the disadvantage of risking poor compliance and causing side-effects especially in children. Nowadays there is considerable interest in alternative therapies or adjunctive treatment against H.P. to reduce some of the drawbacks associated with the antibiotic consumption and to increase the eradication rates. Some adjuvant therapy trials both in adults and in children incorporate probiotics
In our study H.P. eradication was achieved in 82.3% of patients. A little increase in the eradication rate and a significant reduction in side effects were observed in the group treated with triple therapy plus Probinul PB. Resistant patients were offered to second line therapy (omeprazole 1 mg/kg/d, amoxicillin 50 mg/kg/d and metronidazole 20 mg/kg/d), according to NASPGHAN guidelines, confirming the contribution of a high background resistance to clarithromycin. Also, guidelines on HP infection in children issued so far suggest that the antibiotic susceptibility test should be performed whenever available
. However, we did not performed susceptibility test for first line antibiotic therapy.
Probiotics include viable microorganism that have a beneficial effects for the prevention and treatment of specific pathological conditions
. Principle mechanisms include interference with pathogenic toxins, preservation of cellular physiology , interference with pathogen attachment and interaction with normal microbiota
[24, 25] .
In addition, stimulation or modulation of immune responses, both within the lumen and systemically, although not clearly linked to H.P. infection, may contribute
[26, 27]. Besides probiotics may be beneficial in reducing adverse effects and increasing tolerability of HP eradication regimens. Several studies evaluated whether probiotic supplementation might help to prevent or reduce drug-related side effects during H.P. eradication therapy in adults
[28–30]. Up to date, in the pediatric population, few randomized studies have evaluated whether consumption of probiotics could increase H.P. eradication rates and reduce the side effects of treatment
[31–33]. In fact, in a recent trial by Szajewska et al.
 was identified that the use of Lactobacillus GG along with standard triple therapy didn’t resulted in an increased eradication rate and decreased overall therapy-related side effects.
Some of these trials do not provide evidence on the beneficial effect in children of supplementation of probiotics to triple therapy for eradicating H.P. infection nor for positively affecting therapy related symptoms and overall treatment tolerance
However other investigators have shown that in symptomatic H.P. positive children, the occurrence of antibiotic associated side-effects was significantly reduced by the addition of probiotics compared with the placebo supplemented group
H.P. eradication depends on a number of factor, including patients compliance, adverse effects, bacterial resistance, poor drug distribution and concentration, socio-economic conditions and geographic differences. So antibiotic related side effects may be depending on different probiotic strains taken during the H.P. eradication therapy.
In our study the choice of the Probinul probiotic formula was determinated by the fact that it contains high concentration of a wide range of bacteria, as well as inuline as prebiotic. Previously we have demonstrated that this probiotic formula was able to reduce antibiotic gastro-intestinal related side effects in children treated with amoxicillin therapy for pneumonia infections
Besides De Bortoli et al. have demonstrated that the addition of bovine lactoferrin and this probiotic formula to standard triple eradication therapy could improve the H.P. eradication rate and reduce side effects in adult
In this study the combination of standard triple therapy + probiotic + bovine lactoferrin was more effective than triple therapy alone. This could be explained by the combined effect of the bactericidal and bacteriostatic properties of bovine lactoferrin and the mechanism of the probiotics including their direct, nonspecific, bacteriostatic activity and their enhancement of immunoglobulin A production
Probiotics may act through both immunological as well as non-immunological mechanism in H.P. eradication. The latest mechanism includes providing antimicrobial substances, competing with H.P. for adhesion and providing a mucosal barrier. When there are decreases in side effects, compliance improves
. The efficacy of probiotic supplementation for reducing side effects during the course of anti HP regimens appears to be dependent of which probiotic species are used. In fact probiotics must be metabolically active in the intestinal lumen, where they should survive but not persist after the therapy regimen has been completed. They must be acid and bile resistant and should be antagonist to pathogenic bacteria
The present study has shown that the addiction of the Probinul probiotic formula to standard antibiotic treatment reduced in children H.P. therapy-associated side effects (occurrence of side effects: 61.5% in group A vs 14.5% in group B). The H.P. eradication was achieved in 26 of 34 patients in group A (76.4%) and in 30 of 34 patients (88.2%) in group B. Although the success rate was higher in group A than in group B, the different was not significant. Also, we preferred to use the conventional 7-days triple therapy to better highlight the efficacy of probiotic supplement; furthermore extending the duration of therapy form 7 to 14 days is not clearly associated with an increased eradication rate
. However, our study presents some limitations, as a relative small number of patients and absence of a placebo-control group for the probiotics; also, the treatment group with probiotics is likely to be superior to the control group if the sample size is larger.
In conclusion our study suggests that the addition of this probiotic formula to triple therapy did not increase (significantly) the H.P. eradication rates; however it significantly decreased the frequency of epigastric pain, nausea, vomiting and diarrhea.
In children with H.P. infection, we think, there is evidence to recommend the use of this probiotic formula along with standard triple therapy as an option for decreasing overall therapy related side effects and slightly increasing the eradication rates.