Galacto-oligosaccharides Are Bifidogenic and Safe at Weaning: A Double-blind Randomized Multicenter Study

Neonatal Intensive Care Unit, University of Ferrara, Ferrara, Italy.
Journal of pediatric gastroenterology and nutrition (Impact Factor: 2.63). 02/2009; 48(1):82-8. DOI: 10.1097/MPG.0b013e31817b6dd2
Source: PubMed


The primary objective of this study was to determine the bifidogenic effect of galacto-oligosaccharides (GOS) in a follow-on formula and the effects on other intestinal bacteria. Secondary objectives were the effects on stool characteristics, growth, and general well-being.
In a multicenter, double-blind study, 159 healthy infants, formula-fed at enrollment (at 4-6 months), were randomized to an experimental follow-on formula supplemented with 5 g/L (GOS) (77 infants), or to a standard follow-on formula (control, 82 infants). Infants were evaluated at enrollment (study day 1 = sd1), after 6 weeks (study day 2 = sd2), and after an additional 12 weeks (study day 3 = sd3). At each study day, a fresh stool sample for the bacterial counts was collected, and the growth parameters were measured. At sd2, urinary specimens were collected for the evaluation of urinary osmolarity.
At sd2 and sd3, the GOS group had a higher median number (colony-forming units per gram of stool) of bifidobacteria than did the control group (sd2 GOS 9.2 x 10(9) vs control 4.4 x 10(9), P = 0.012); (sd3 GOS 7.2 x 10(9) vs control 2.4 x 10(9), P = 0.027). Other bacteria did not show any significant differences between the 2 groups at all study days. The GOS produced softer stools but had no effect on stool frequency. The urinary osmolarity (mOsm/L) at sd2 was comparable in both groups. Supplementation had no influence on the incidence of gastrointestinal side effects or on the growth of the infants.
These data indicate that the addition of GOS (5 g/L) to a follow-on formula positively influences the bifidobacteria flora and the stool consistency in infants during the supplementation period at weaning. No local or systemic side effects were recorded.

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    • "According to Brunser 2006 [38], there was no difference in the number of Enterobacteria counts between the prebiotic and control groups (MD −0.48, 95% CI: -1.88 to 0.22, n = 43). Fanaro 2008 [43] reported the median (IQR) of Enterobacteria (log10 CFU per gram stool) (Table 8). "
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    ABSTRACT: Background Synbiotics, probiotics or prebiotics are being added to infant formula to promote growth and development in infants. Previous reviews (2007 to 2011) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity. This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics, probiotics or prebiotics. Methods Cochrane methodology was followed using randomized controlled trials (RCTs) which compared term infant formula containing probiotics, prebiotics or synbiotics to conventional infant formula with / without placebo among healthy full term infants. The mean difference (MD) and corresponding 95% confidence intervals (CI) were reported for continuous outcomes, risk ratio (RR) and corresponding 95% CI for dichotomous outcomes. Where appropriate, meta-analysis was performed; heterogeneity was explored using subgroup and sensitivity analyses. If studies were too diverse a narrative synthesis was provided. Results Three synbiotic studies (N = 475), 10 probiotics studies (N = 933) and 12 prebiotics studies (N = 1563) were included. Synbiotics failed to significantly increase growth in boys and girls. Use of synbiotics increased stool frequency, had no impact on stool consistency, colic, spitting up / regurgitation, crying, restlessness or vomiting. Probiotics in formula also failed to have any significant effect on growth, stool frequency or consistency. Probiotics did not lower the incidence of diarrhoea, colic, spitting up / regurgitation, crying, restlessness or vomiting. Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain. Prebiotics increased stool frequency but had no impact on stool consistency, the incidence of colic, spitting up / regurgitation, crying, restlessness or vomiting. There was no impact of prebiotics on the volume of formula tolerated, infections and gastrointestinal microflora. The quality of evidence was compromised by imprecision, inconsistency of results, use of different study preparations and publication bias. Authors’ conclusions There is not enough evidence to state that supplementation of term infant formula with synbiotics, probiotics or prebiotics does result in improved growth or clinical outcomes in term infants. There is no data available to establish if synbiotics are superior to probiotics or prebiotics.
    Nutrition Journal 10/2012; 11(1):81. DOI:10.1186/1475-2891-11-81 · 2.60 Impact Factor
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    • "The stool softening effect demonstrated with the blend of PDX and GOS or GOS alone may potentially help manage hard stools that could affect formula-fed infants [37]. In general, softer, looser stools are characteristic of both breastfed infants and infants who receive formula supplemented with prebiotics when compared to those who receive unsupplemented formulas [11,38,39]. In healthy, term infants we previously reported that use of routine formulas supplemented with PDX and GOS produced a bifidogenic effect closer to breast milk compared to formula without PDX and GOS [12]. "
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    ABSTRACT: To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow's milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone. In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow's milk-based infant formula (Control; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN) (n = 142) or one of two investigational formulas from 14 to 120 days of age. Investigational formulas were supplemented with 4 g/L (1:1 ratio) of a prebiotic blend of PDX and GOS (PDX/GOS; n = 139) or 4 g/L of GOS alone (GOS; n = 138). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120 days of age. Medically-confirmed adverse events were recorded throughout the study. There were no group differences in growth rate from 14 to 120 days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher (i.e. softer stools) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group (all P < 0.05). The overall incidence of medically-confirmed adverse events was similar among groups. Investigational routine infant formulas supplemented with 4 g/L of either a prebiotic blend of PDX and GOS or GOS alone were well-tolerated and supported normal growth. Compared to infants who received the unsupplemented control formula, infants who received prebiotic supplementation experienced a softer stooling pattern similar to that reported in breastfed infants. Identifier: NCT00712608.
    Nutrition Journal 06/2012; 11(1):38. DOI:10.1186/1475-2891-11-38 · 2.60 Impact Factor
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    • "D&apos;souza and others (2010) GOS Mice No detectable effect on the intestine villus height, total protein content, and sucrase activity were found to be increased, an increase in O-linked glycoproteins associated with the intestinal mucosa was also observed. Leforestier and others (2009) GOS (formula food supplemented with GOS) Human GOS group had a significantly higher content of fecal bifidobacteria compared with the control group Fanaro and others (2009) Formula food supplemented with GOS Human At the end of a 3-mo feeding period, the number of intestinal bifidobacteria and lactobacilli was significantly increased both in GOS-supplemented formula-fed infants and in breast-fed infants, compared with those fed with the control formula. No difference was seen between the GOS formula-feeding and breast-feeding groups. "
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    ABSTRACT: Since introduction of functional foods, commercialization of the traditionally used probiotics has ushered in more followers into the new fraternity of sophisticated, health-conscious consumers. In 1995, this was followed by the first introduction of prebiotics. Prebiotics are defined as "a non-digestible feed supplement, beneficially affecting the host by selectively stimulating growth and/or activity in one or a limited number of bacteria in the colon." The number of new product introductions with prebiotics has steeply increased over the last few years. Paradoxically, probiotics have limited applications as these cannot be used in wide range of food products because of their viability issue. Fortunately, prebiotics do not suffer from any such constraint and can be used in a wide range of food products. Probiotics do not have a long shelf life in their active form. In most cases, refrigeration is required to maintain the shelf life. While probiotics are predominantly used in fermented dairy products, the use of prebiotics has expanded into other food categories. Prebiotics have successfully been incorporated in a wide variety of human food products such as baked goods, sweeteners, yoghurts, nutrition bars, and meal replacement shakes. For instance, the introduction of galacto-oligosaccharides (GOS) into baby foods has been very successful. GOS, which are identical to the human milk oligosaccharides, has emerged with strong clinical support for both digestive and immune health. Various aspects related to GOS such as types and functions of functional food constituents with special reference to GOS, their role as prebiotics, and enhanced industrial production through microbial intervention are dealt in this review.
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