Background and objectives: There is accumulating evidence that human milk oligosaccharides play a crucial role on the intestinal microbiota. The principal objective was to demonstrate in healthy term infants the effect of a Galacto-oligosaccharides (GOS) supplemented infant formula (0.4g/100mL)in stimulating prebiotic effect. Methods: This was a randomized, double blind, controlled, clinical trial performed by 6 centers in Italy Three groups were considered: breast milk, GOS supplemented infant formula (study formula) and standard infant formula (control formula). Study and control formula were supplied by Heinz Italia S.p.A. (Latina, Italy). Anthropometric parameters were recorded at: baseline visit (B) within 15 days after birth, visit V1 (30 ± 10 days of life), visit V2 (60 ± 10 days of life), visit V3 (90 ± 10 days of life), visit V4 (120 ± 10 days of life) and final visit (Vf), before the introduction of complementary feeding. A fecal sample was collected at B, V1, V2 and Vf. Bifidobacteria, Lactobacilli, Clostridium, Escherichia coli were evaluated. Total bacterial DNA was extracted from faecal samples and subsequent qPCR analysis was performed. Results: A total of 199 breast fed infants and 163 formula fed (80 in the control group and 83 in the study group) were recruited. All three groups showed appropriate physical development throughout the period. Study formula presented normal and soft tools in the majority of episodes (89%). Ratio betweenClostridium count and Bifidobacteria and Lactobacilli count was significantly more favourable when considering the study formula group with respect to the control one during the entire follow up (P=0.02). Conclusions: Our study showed that the GOS supplemented formula mimicked the effect of human milk in promoting Bifidobacteria and Lactobacilli growth as well as in inhibiting Clostridium.This trial is registered with ClinicalTrials.gov, numberNCT00486148.
PREBIOTIC EFFECT OF A FORMULA SUPPLEMENTED WITH GALACTO-OLIGOSACCHARIDES IN TERM INFANTS: A RANDOMIZED MULTICENTER TRIAL / M., Giovannini; E., Verduci; G., Zuccotti; Biasucci, G; A., Podestà; A., Rottoli; D., Gregori; S., Ballali; S., Soldi; G., Banderali; D., Ghisleni; E., Riva. - In: ANNALS OF NUTRITION & METABOLISM. - ISSN 1421-9697. - 63:suppl.1(2013), p. 1667.
PREBIOTIC EFFECT OF A FORMULA SUPPLEMENTED WITH GALACTO-OLIGOSACCHARIDES IN TERM INFANTS: A RANDOMIZED MULTICENTER TRIAL
Biasucci G;
2013-01-01
Abstract
Background and objectives: There is accumulating evidence that human milk oligosaccharides play a crucial role on the intestinal microbiota. The principal objective was to demonstrate in healthy term infants the effect of a Galacto-oligosaccharides (GOS) supplemented infant formula (0.4g/100mL)in stimulating prebiotic effect. Methods: This was a randomized, double blind, controlled, clinical trial performed by 6 centers in Italy Three groups were considered: breast milk, GOS supplemented infant formula (study formula) and standard infant formula (control formula). Study and control formula were supplied by Heinz Italia S.p.A. (Latina, Italy). Anthropometric parameters were recorded at: baseline visit (B) within 15 days after birth, visit V1 (30 ± 10 days of life), visit V2 (60 ± 10 days of life), visit V3 (90 ± 10 days of life), visit V4 (120 ± 10 days of life) and final visit (Vf), before the introduction of complementary feeding. A fecal sample was collected at B, V1, V2 and Vf. Bifidobacteria, Lactobacilli, Clostridium, Escherichia coli were evaluated. Total bacterial DNA was extracted from faecal samples and subsequent qPCR analysis was performed. Results: A total of 199 breast fed infants and 163 formula fed (80 in the control group and 83 in the study group) were recruited. All three groups showed appropriate physical development throughout the period. Study formula presented normal and soft tools in the majority of episodes (89%). Ratio betweenClostridium count and Bifidobacteria and Lactobacilli count was significantly more favourable when considering the study formula group with respect to the control one during the entire follow up (P=0.02). Conclusions: Our study showed that the GOS supplemented formula mimicked the effect of human milk in promoting Bifidobacteria and Lactobacilli growth as well as in inhibiting Clostridium.This trial is registered with ClinicalTrials.gov, numberNCT00486148.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
