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: L actobacillus casei , L . rhamnosus , S treptococcus thermophilus , B ifidobacterium breve , L . acidophilus , B . infantis , L . bulgaricus and fructooligosacharide ( P rotexin Healthcare, S omerset, 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.