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FIPS study: GI benefits of fermented formula plus prebiotics

Study title

Randomised controlled trial demonstrates that fermented infant formula with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides reduces the incidence of infantile colic.

Official registration: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2521

Study Objective

To examine the effects on gastrointestinal (GI) tolerance of a novel infant formula that combined specific fermented formula (FERM) with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS).

The FIPS abbreviation stands for Fermented Infant Formula with Prebiotics Study.

Description

The development of a healthy GI system in early life is key as it impacts on an infant’s immune, metabolic and neuronal systems. As GI and microbiota development is complex and highly dynamic, healthy term-born infants can suffer from a number of functional GI disorders and related signs and symptoms, including infantile colic.

Methodology

The FIPS study1 was a double-blind, randomised, four-arm parallel group, controlled, multicentre equivalence trial, looking at growth, safety and GI tolerance. Four hundred and thirty one (431) term-born infants age 0-28 days, whose parents decided not to start, or discontinued breastfeeding, were randomly assigned to one of the four parallel groups.

The groups received infant formula containing one of the following:
(1) scGOS/lcFOS+50%FERM,
(2) scGOS/lcFOS+15%FERM,
(3) 50%FERM,
(4) scGOS/lcFOS.

Parents completed standardised seven-day diaries on GI symptoms, crying, sleeping and stool characteristics each month until the infants were 17 weeks.

Countries: France, Belgium and Ireland.

Study results

All the formulas were well tolerated.
The combination of scGOS/lcFOS and 50% FERM showed a consistent stool softening when it was compared to the formula without scGOS/lcFOS. It also showed a significantly lower incidence of infantile colic at four weeks of age, when compared to formulas that contained either FERM or scGOS/lcFOS.

Interestingly, longitudinal modelling of daily crying duration over the 17 weeks of the intervention showed that scGOS/lcFOS+50%FERM-fed infants also displayed a persistently lower daily crying duration throughout the study period.

These findings suggest for the first time that a specific infant formula has a preventive effect on infantile colic in formula-fed infants.

View References

1.
Vandenplas Y, et al. Acta Paediatr 2017;106(7):1150-58.