Background and aims The effects on gastrointestinal (GI) tolerance and prevalence of colics (secondary outcome parameters) of a novel infant formula (IF) were explored in a randomised, controlled, double-blind, multicenter intervention study on growth, safety and GI tolerance. The novel IF combined the fermented IF Lactofidus™(LF) with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS, ratio 9:1, 0.8 g/100 ml).

Methods 432 healthy, term infants aged 0–28 days were randomised after parent’s autonomous decision to discontinue breastfeeding. IF with scGOS/lcFOS and 50%LF (LF50+), IF with scGOS/lcFOS and 15%LF (LF15+), and as controls IF with 50%LF (LF50), or IF with scGOS/lcFOS (IF+) were tested. Parents completed standardised 7-day diaries with daily entries on GI symptoms and crying in monthly intervals until 17 weeks of age. Colic was defined by adapted Rome III criteria.

Results Growth and safety outcomes were within the normal ranges. Based on low mean GI symptom-scores, the newly-developed IFs were well tolerated. The incidence of colic was highest (16.1%) at the 4 week visit and in line with literature (i.e. 20.5% at 4 weeks of age [Iacono et al ., 2005]). The incidence of colic was significantly lower with LF50+ (8%) compared to IF+ (20%)(p = 0.034; chi-square test), and LF50 (20%)(p = 0.036) at the 4 week visit. Colic was found to be associated with clinically relevant flatulence, abdominal distension, constipation, diarrhoea, and regurgitation at four weeks of age.

Conclusions The combination of scGOS/lcFOS with 50% fermented IF displayed a 60% lower incidence of colic in infants at 4 weeks of age compared to control IFs.