This pilot study showed that intake of Bifidobacterium breve for 4 weeks, significantly increased the defecation frequency. Furthermore, stool consistency, the frequency of episodes of faecal incontinence and the frequency of abdominal pain significantly changed after the use of this specific probiotic strain.
A recent systematic review on the effects of laxative treatment and dietary measures in the management of childhood constipation found only 2 randomized controlled trials evaluating the effects of probiotics . In the first small study, 45 children younger than 10 years with chronic constipation were randomly assigned to receive magnesium oxide (50 mg/kg/day (n = 18), or 8 × 108 cfu/day of the probiotic Lactobacillus casei rhamnosus (n = 18), or placebo (n = 9) twice daily for 4 weeks . No statistically significant difference in the defecation frequency per day was found between the probiotic group and the magnesium oxide group. However, patients receiving either the probiotic strain or the oral laxative had a significantly higher defecation frequency compared to the placebo group (defecation frequency [times/day 0.57 ± 0.17 and 0.55 ± 0.13, respectively, compared to 0.37 ± 0.10, p = 0.03). The second trial was conducted to determine if Lactobacillus rhamnosus GG (LGG) is an effective adjunct to lactulose for treating constipation in children. A total of 48 children with constipation received 1 ml/kg/day of 70% lactulose plus 109 cfu of LGG or 1 ml/kg/day of 70% lactulose plus placebo, twice daily for 12 weeks . There were no significant differences in rates of product success (defined as ≥ 3 spontaneous stools per week with no faecal incontinence) at 12 and 24 weeks between the LGG group (rates: 72% and 64%, respectively) and the placebo group (rates: 68% and 65%, respectively). `
In a recent trial, 44 children, at least 6 months old, with chronic constipation were randomly assigned to receive supplementation with the probiotic Lactobacillus reuteri (DSM 17938) (n = 22) or placebo (n = 22) . Infants receiving Lactobacillus reuteri had a significantly higher frequency of bowel movements than infants receiving a placebo at week 8 of supplementation (2.82 per week at week 0, compared with 4.77 at week 8 in the probiotic group, absolute numbers not given for placebo group, P = 0.027). There was no significant difference between Lactobacillus reuteri and placebo groups in the stool consistency at all weeks nor in the presence of inconsolable crying episodes. All three trials did not report any adverse events in the probiotic group.
A mixture of probiotics (containing Bifidobacteria (B.) bifidum, B. infantis, B. longum, Lactobacillus (L.) casei, L. plantarum and L. rhamnosus), increased the number of bowel movements, decreased the number of faecal incontinence episodes and improved the consistency of stools . Although the results of this small pilot study are positive, a large randomized controlled trial is necessary to confirm these data.
It is unknown why the outcome of the above mentioned trials in constipated children is so different. We speculate that the use of different inclusion criteria for paediatric constipation with consequently different study populations and the use of different probiotic strains, given in different dosages with variable duration of the treatment period, influence study outcomes.
In contrast to the few paediatric studies, data suggest that adults with constipation might benefit from ingestion of B. lactis DN-173 010, L. casei Shirota, and E. coli Nissle 1917. All studies showed an increased defecation frequency and improved stool consistency . These findings, however are not directly applicable to the paediatric population because constipation in children differs considerably from that in constipated adults with regard to its prevalence, onset, aetiology, symptoms, treatment, and prognosis .
Besides the increase in defecation frequency and decrease in episodes of faecal incontinence, this study also showed a significant effect in softening of stools and in decreasing abdominal pain. Both effects could be a direct consequence an increase in defecation but theoretically, it could also be caused by the working mechanism of the probiotics. It has been assumed that probiotics soften the stools by stimulating water and electrolyte secretion [22, 23]. Furthermore, one paediatric study and several studies in adults with irritable bowel syndrome (IBS), have demonstrated that abdominal pain decreased when using probiotics [17, 24, 25]. Whorwell et al. conducted a randomized trial in 360 women with IBS receiving Bifidobacterium infantis and found a significant improvement of abdominal pain which occurred irrespective of any effect on stool frequency. The authors hypothesized that the probiotics were able to diminish visceral hypersensitivity by its anti-inflammatory effect on the enteric mucosa .
According to the available data, it is assumed that the risk of infection with the probiotic lactobacilli or bifidobacteria is similar to risks with commensal strains . However, there is concern that the use of probiotics may result in harmful events in at-risk populations like immunocompromized subjects or in patients with other life-threatening illnesses, who were admitted in the intensive care unit. Based on our results and their safety profile, adding probiotics to the standard treatment of functional constipation in otherwise healthy children is promising. The major limitation of our study is that this study is a non randomized non placebo controlled small pilot study. However, since this study shows promising results it is worthwhile to perform a large RCT to unravel the efficacy of Bifidobacterium breve in constipated children.
In conclusion, this small pilot study suggests that Bifidobacterium breve is effective in the treatment of childhood constipation. A large randomized placebo controlled trial is now required to confirm these data.