Synbiotic in the management of infantile colic: a randomised controlled trial.

AIM Infant colic is a frequent problem affecting up to 10-30% of infants in first 3 months of life. Results from previous trials have shown that manipulation of gut microbiota can lead to symptomatic improvements. In a randomised clinical trial, we aimed to determine efficacy of synbiotic in reducing average infant crying time at day 7 and day 30 after starting intervention. METHODS Fifty breastfed infants aged 15-120 days with infantile colic randomly assigned to receive either the synbiotic sachet containing 1 billion CFU of: Lactobacillus casei, L. rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, L. acidophilus, B. infantis, L. bulgaricus and fructooligosacharide (Protexin Healthcare, Somerset, UK), or placebo daily for 30 days. Parents were asked to record details of crying times in a symptoms diary. The primary outcome measure was the treatment success (reduction in the daily crying time >50%) and the secondary outcome measure was symptom resolution (reduction in the daily crying time >90%). RESULTS The treatment success was significantly higher in synbiotic group (82.6%) compared with placebo (35.7%) at day 7 (P < 0.005). At day30, treatment success was 87% and 46% in synbiotic and placebo group, respectively (P < 0.01). Symptom resolution was also higher in synbiotic group (39%) compared with placebo (7%) at day 7 (P < 0.03) but not at day 30 (56% vs.36%, P = 0.24). We encountered no complication related to synbiotic use. CONCLUSION This synbiotic (a mixture of seven probiotic strains plus FOS) significantly improved colic symptoms in comparison with placebo.