Research Study

Methods

50 breastfed infants aged 15 – 120 days diagnosed with infantile colic according to Wessel’s criteria, but otherwise healthy, were randomly assigned to receive either the synbiotic sachet (7 bacteria strains + prebiotic; 1 billion CFU per day), 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%). No other medications were used.

Results

Out of the initial 50 infants, 25 from synbiotic and 20 from placebo arm completed the study. At baseline, infants in both groups were crying approximate 190 minutes a day and had 4-5 colic episodes per day. Both groups had a similar proportion of vaginal and caesarean deliveries (respectively 40 and 60%), and 75% of the infants in both groups had familial history of allergy.

The treatment success at day 7 was significantly higher in the synbiotic group compared with placebo (82.6% vs 35.7%; p < 0.005), which remained significantly different at day 30 (87% vs 46%; p<0.01).

Symptom resolution was also higher in the synbiotic group compared with placebo at day 7 (39% vs 7%; p< 0.03), and at day 30 (56% vs 36% p = 0.24).

At both day 7 and day 30, infants in the synbiotic group cried on average over 30 minutes less than infants in the placebo group. No adverse events were reported.

Conclusions

The multi-strain synbiotic, achieved a statistically significant reduction in cry and fuss time, evident within the first 7 days, without adverse effects.