A synbiotic mixture for the management of infantile colic: A randomized trial

Infant colic is defined as a recurrent and prolonged period of fussing, crying and/or irritability that cannot be prevented or resolved by caregivers. The aim of this study is to evaluate the efficacy of a synbiotic (Bactecal D Liquid) in infants consulting a primary health care professional for inconsolable crying. A randomized trial was conducted in 68 infants diagnosed by the consulted primary health care professional as "probably suffering from infant colic". Patients were randomized into two groups and given the synbiotic once (group 1) or twice (group 2) a day for 28 days. Quality of life (QoL) of the caregivers, evaluated with a Likert scale, was the primary outcome. Secondary outcomes included the total number of crying episodes, total crying time, gassiness and "balling of the fists". The median (Q1;Q3) QoL scores were significantly (p < 0.001) higher on day 28 than at baseline: 6 (5;7) vs 2 (1;3). At baseline, there was no significant difference (p = 0.527) in QoL between both groups. The improvement in QoL was already significant after one week of intervention for both groups. The median number of crying episodes, overall crying time, gassiness and "balling of fists" were significantly lower on day 28 compared to baseline (p < 0.001).

The synbiotic tested was shown to be efficacious in the management of infant colic. A significant improvement was observed after 7 days of intervention, which is much earlier than the expected decrease related to the natural evolution of infant colic.

• Some probiotic strains are reported to be effective in the management of infants presenting with colic, if breastfed.

• The synbiotic studied improved quality of life of caregivers of infants presenting infant colic. • Two doses of the synbiotic were not more effective than one dose. • The improved occurred within one week. • The improvement was independent of feeding (breastfeeding, formula feeding or mixed feeding).