The clinical study, funded by Danone Nutricia, examined the effects on gastrointestinal (GI) tolerance of a novel infant formula that combined a specific fermented formula with prebiotics short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS).
This prospective, double-blind, randomised, controlled trial comprised 432 healthy infants aged 0–28 days whose parents decided to not start, or discontinued, breastfeeding. Four types of formula were used, with parents completiting seven-day diaries on GI symptoms, crying, sleeping and stool characteristics each month until the infants were 17 weeks old.
The results found that a combination of fermented formula with scGOS/lcFOS was well tolerated and showed a lower overall crying time, a lower incidence of infantile colic and a stool-softening effect in healthy term infants.
Dr Thomas Ludwig, from Nutricia Research, told us: “The formula is a unique and new combination of two established concepts with reported gut health benefits: the prebiotic mixture of scGOS/lcFOS (0.8 g/100 ml, 9:1) with a specific fermented formula.
“Both concepts have been used in infant formulas for more than a decade each, yet the combination of both is new. The final product contains micro and macronutrients, including intact proteins, that meet international infant formula standards, and is fully compliant with infant food regulations.”
The cause of infantile colic is essentially unknown, and most likely multifactorial, but it has been hypothesised that it is linked to the complex development of the digestive system early in life.
“However, the findings from the currently published clinical study suggest for the first time that a specific infant formula can have a preventive effect on infantile colic,” he added.
“The novel infant formula combines specific fermented formula with prebiotics scGOS/lcFOS. Based on the study results its benefits are expected to be a result of the combined functionalities of both."
The prebiotic mixture of scGOS/lcFOS mimics the functionality of oligosaccharides in human milk, he added.
“It has been shown in several clinical trials to increase the level of beneficial gut bacteria, and produce softer and more frequent stools similar to those found in breastfed infants. It has also been reported in clinical studies to reduce incidence of allergic diseases and infections.”
Further studies will now be conducted to assess its suitability in regard to new product development.
“The results of the clinical study that were just published are part of a translational research program which includes preclinical science, further clinical studies, and the generation of ‘real life’ insights to learn more about the beneficial effects of the new formula in the broadest meaning of sense,” added Dr Ludwig.
“The concept is very interesting and will be explored further.”
Source: Acta Paediatrica
"Randomised controlled trial demonstrates that fermented infant formula with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides reduces the incidence of infantile colic."
Authors: Yvan Vandenplas, et al.