Incidence of infectious diseases in infants fed follow-on formula containing synbiotics: an observational study.
ABSTRACT: AIM: Infectious diseases in infants are a major public health issue. Synbiotic-enriched formulas (EF) are intended to mimic the beneficial effects of human milk on infectious diseases. We performed an observational study in infants switching to follow-on formula to determine the effects of synbiotic-enriched formula compared to standard formula (SF). METHODS: We recorded family characteristics, medical history and growth data, as well as the symptoms, severity and treatment of infectious diseases. Main outcome measures were compared after adjustments for baseline characteristics. RESULTS: Between January and June 2007, 771 healthy infants were included in the study; 35.4% experienced at least one infectious disease during the 3-month study period. The most common were upper respiratory tract (24.1%), otitis (6.6%) and gastrointestinal infectious diseases (5.0%). Infants fed synbiotic-enriched formula had fewer infectious diseases overall (EF: 31.0%; SF: 40.6%; p = 0.005) and significantly fewer gastrointestinal infectious diseases (EF: 3.5%; SF: 6.8%; p = 0.03). During follow-up, weight gain was significantly higher (p = 0.0467) in infants fed synbiotic-enriched formula (18.3 ± 8.7 g/day) versus SF (16.9 ± 7.5 g/day). CONCLUSIONS: Supplementation with synbiotics may have beneficial effects on the incidence of infectious disease and growth in infants. Further studies are needed determine optimal doses and composition of synbiotics in infant formula.
Project description:BACKGROUND/OBJECTIVES: Protein concentration is lower in human milk (HM) than in infant formula. The objective of this study was to evaluate the effect of an α-lactalbumin-enriched formula with a lower protein concentration on infant growth, protein markers and biochemistries. SUBJECTS/METHODS: Healthy term formula-fed (FF) infants 5-14 days old were randomized in this controlled, double-blind trial to standard formula (SF: 14.1 g/l protein, 662 kcal/l) group (n=112) or experimental formula (EF: 12.8 g/l protein, 662 kcal/l) group (n=112) for 120 days; a HM reference group (n=112) was included. Primary outcome was weight gain (g/day) from D0 to D120. Secondary outcomes included serum albumin, plasma amino acids insulin and incidence of study events. Anthropometric measures were expressed as Z-scores using 2006 World Health Organization growth standards. RESULTS: A total of 321 of the 336 infants (96%) who enrolled, completed the study. Mean age was 9.6 (±2.9) days; 50% were girls. Mean weight gain (g/day) did not significantly differ between SF vs EF (P=0.67) nor between EF vs HM (P=0.11); however weight gain (g/day) was significantly greater in the SF vs HM group (P=0.04). At day 120, mean weight-for-age Z-score (WAZ) and weight-for-length Z-score (WLZ) did not significantly differ between SF vs EF nor EF vs HM; however the WAZ was significantly greater in SF vs HM (P=0.025). Secondary outcomes were within normal ranges for all groups. Incidence of study events did not differ among groups. CONCLUSIONS: α-Lactalbumin-enriched formula containing 12.8 g/l protein was safe and supported age-appropriate growth; weight gain with EF was intermediate between SF and HM groups and resulted in growth similar to HM-fed infants in terms of weight gain, WAZ and WLZ.
Project description:Postnatal nutrition is essential for growth and neurodevelopment. We analyzed the influence of a new enriched-infant formula with bioactive compounds on growth, neurodevelopment, and visual function (VF) in healthy infants during their first 18 months of life. A total of 170 infants were randomized in the COGNIS randomized clinical trial (RCT) to receive a standard infant formula (SF = 85) or a new experimental infant formula supplemented with functional nutrients (EF = 85). As a control, 50 breastfed infants (BF) were enrolled. Growth patterns were evaluated up to 18 months of life; neurodevelopment was assessed by general movements at 2, 3, and 4 months; VF was measured by cortical visual evoked potentials at 3 and 12 months. No differences in growth and neurodevelopment were found between groups. Regarding VF, SF and EF infants presented prolonged latencies and lower amplitudes in the P100 wave than BF infants. In the EF group, a higher percentage of infants presented response at 7½'of arc at 12 months compared to 3 months of age; a similar proportion of BF and EF infants presented responses at 7½'of arc at 12 months of age. Early nutritional intervention with bioactive compounds could narrow the gap in growth and neurodevelopment between breastfed and formula-fed infants.
Project description:BackgroundPrebiotics and probiotics (synbiotics) can modify gut microbiota and have potential in allergy management when combined with amino-acid-based formula (AAF) for infants with cow's milk allergy (CMA).MethodsThis multicenter, double-blind, randomized controlled trial investigated the effects of an AAF-including synbiotic blend on percentages of bifidobacteria and Eubacterium rectale/Clostridium coccoides group (ER/CC) in feces from infants with suspected non-IgE-mediated CMA. Feces from age-matched healthy breastfed infants were used as reference (healthy breastfed reference (HBR)) for primary outcomes. The CMA subjects were randomized and received test or control formula for 8 weeks. Test formula was a hypoallergenic, nutritionally complete AAF including a prebiotic blend of fructo-oligosaccharides and the probiotic strain Bifidobacterium breve M-16V. Control formula was AAF without synbiotics.ResultsA total of 35 (test) and 36 (control) subjects were randomized; HBR included 51 infants. At week 8, the median percentage of bifidobacteria was higher in the test group than in the control group (35.4% vs. 9.7%, respectively; P<0.001), whereas ER/CC was lower (9.5% vs. 24.2%, respectively; P<0.001). HBR levels of bifidobacteria and ER/CC were 55% and 6.5%, respectively.ConclusionAAF including specific synbiotics, which results in levels of bifidobacteria and ER/CC approximating levels in the HBR group, improves the fecal microbiota of infants with suspected non-IgE-mediated CMA.
Project description:Nutrition during early life is essential for brain development and establishes the basis for cognitive and language skills development. It is well established that breastfeeding, compared to formula feeding, has been traditionally associated with increased neurodevelopmental scores up to early adulthood. We analyzed the long-term effects of a new infant formula enriched with bioactive compounds on healthy children's language development at four years old. In a randomized double-blind COGNIS study, 122 children attended the follow-up call at four years. From them, 89 children were fed a standard infant formula (SF, n = 46) or an experimental infant formula enriched with functional nutrients (EF, n = 43) during their first 18 months of life. As a reference group, 33 exclusively breastfed (BF) were included. Language development was assessed using the Oral Language Task of Navarra-Revised (PLON-R). ANCOVA, chi-square test, and logistic regression models were performed. EF children seemed to show higher scores in use of language and oral spontaneous expression than SF children, and both SF and EF groups did not differ from the BF group. Moreover, it seems that SF children were more frequently categorized into "need to improve and delayed" in the use of language than EF children, and might more frequently present "need to improve and delayed" in the PLON-R total score than BF children. Finally, the results suggest that SF children presented a higher risk of suffering language development than BF children. Secondary analysis also showed a slight trend between low socioeconomic status and poorer language skills. The functional compound-enriched infant formula seems to be associated with beneficial long-term effects in the development of child's language at four years old in a similar way to breastfed infants.
Project description:In a recent study, supplementation of infant formula with milk fat globule membranes (MFGM) decreased the incidence of otitis media in infants <6 months of age.The aim of the present study was to characterize the oral microbiota in infants fed MFGM-supplemented formula and compare it to that of infants fed standard formula or breast milk.In a prospective double-blinded randomized controlled trial, exclusively formula-fed infants <2 months of age were randomized to be fed experimental formula (EF, n = 80) with reduced energy and protein and supplemented with a bovine MFGM concentrate, or standard formula (SF, n = 80) until 6 months of age. A breast-fed reference (BFR, n = 80) group was also recruited. The oral microbiota was analyzed at 4 (n = 124) and 12 (n = 166) months of age using Illumina MiSeq multiplex sequencing and taxonomic resolution against the HOMD 16S rDNA database of oral bacteria.Species richness in the oral samples did not differ between the EF and SF groups, but partial least square modeling identified a few taxa that were significantly associated with being in either group, e.g. lower level of Moraxella catarrhalis in the EF group. Infants in the BFR group had significantly lower species richness at 4 months of age and their microbiota pattern differed markedly from the formula-fed groups.Supplementation of infant formula with MFGM yielded moderate effects on the oral microbiome. Moraxella catarrhalis was less prevalent in infants fed EF than in those fed SF and may be associated with the decrease in otitis media seen in the same group.
Project description:Formula-fed (FF) infants exhibit a different metabolic profile than breast-fed (BF) infants. Two potential mechanisms are the higher protein level in formula compared with breast milk and the removal of the milk fat and associated milk fat globule membranes (MFGM) during production of infant formula. To determine whether MFGM may impact metabolism, formula-fed infants were randomly assigned to receive either an MFGM isolate-supplemented experimental formula (EF) or a standard formula (SF) from 2 until 6 months and compared with a BF reference group. Infants consuming EF had higher levels of fatty acid oxidation products compared to infants consuming SF. Although the protein level in the study formula was approximately 12?g/L (lower than most commercial formulas), a metabolic difference between FF and BF remained such that FF infants had higher levels of amino acid catabolism by-products and a low efficiency of amino acid clearance (preference for protein metabolism). BF infants had higher levels of fatty acid oxidation products (preference for fat metabolism). These unique, energy substrate-driven metabolic outcomes did not persist after diet was shifted to weaning foods and appeared to be disrupted by complementary feeding. Our results suggest that MFGM may have a role in directing infant metabolism.
Project description:Human milk delivers an array of bioactive components that safeguard infant growth and development and maintain healthy gut microbiota. Milk fat globule membrane (MFGM) is a biologically functional fraction of milk increasingly linked to beneficial outcomes in infants through protection from pathogens, modulation of the immune system and improved neurodevelopment. In the present study, we characterized the fecal microbiome and metabolome of infants fed a bovine MFGM supplemented experimental formula (EF) and compared to infants fed standard formula (SF) and a breast-fed reference group. The impact of MFGM on the fecal microbiome was moderate; however, the fecal metabolome of EF-fed infants showed a significant reduction of several metabolites including lactate, succinate, amino acids and their derivatives from that of infants fed SF. Introduction of weaning food with either human milk or infant formula reduces the distinct characteristics of breast-fed- or formula-fed- like infant fecal microbiome and metabolome profiles. Our findings support the hypothesis that higher levels of protein in infant formula and the lack of human milk oligosaccharides promote a shift toward amino acid fermentation in the gut. MFGM may play a role in shaping gut microbial activity and function.
Project description:Background: Canine chronic enteropathies (CE) are a group of intestinal diseases that can be categorized based on treatment response into diet- or food- responsive enteropathy (FRD), antibiotic-responsive enteropathy, steroid-responsive enteropathy, and non-responsive enteropathy. CE can often be associated with intestinal dysbiosis and thus administration of probiotic or synbiotic products may provide a useful tool for the management of some of these patients. Enterococcus faecium (EF) is a probiotic strain included in a commercially available synbiotic for small animals, however its impact on the microbial communities in dogs with FRD has not yet been evaluated. Hypothesis/Objectives: The administration of a synbiotic will lead to a significant difference of the fecal microbial composition and/or diversity in dogs with FRD, and these changes are not attributable to diet change alone. Animals/Samples: Twelve dogs with FRD fed a hydrolyzed protein diet received either a synbiotic (EF, fructooligosaccharides, gum Arabic) or placebo. Fecal samples were taken before and 6 weeks into treatment. Fecal samples were also acquired from 8 healthy dogs before and 6 weeks after being switched to the same hydrolyzed protein diet as their sole food. Methods: Bacterial DNA was extracted from fecal samples and next generation sequencing based on the 16S rRNA genes was performed. Microbial composition and diversity between groups were compared using QIIME. Results: There was a small increase in species diversity in the feces of dogs with FRD treated with synbiotics. However, there were no significant differences in microbial community composition before and after 6 weeks in either the synbiotic or placebo treated dogs with FRD or the healthy dogs. In all groups, large individual variations were observed. Conclusions: No changes in microbial composition were observed in diseased or healthy dogs with diet change alone. However, administration of a synbiotic increased bacterial richness in both groups.
Project description:The scoping review aimed to examine the evidence on the role of synbiotics in caries prevention. PubMed, SCOPUS, and Web of Science databases search were performed. Any in vitro study, clinical trial, systematic review with/without meta-analysis, umbrella review/meta-evaluation, narrative review addressing the role of synbiotics in caries prevention were included in the scoping review. Data were extracted from the included studies using pre-approved registered protocol. Twenty-eight records were identified, of which 5 in vitro studies, 1 quasi-experimental clinical trial and 1 narrative review were included in the present review. No controlled clinical trials or systematic reviews on the role of synbiotics in caries prevention could be identified. Except 1, all in vitro studies examined the combined effect of saccharides and lactobacilli spp. as potential synbiotics on the growth of Streptococcus mutans. However, the proposed synbiotics in 4 in vitro studies either did not qualify or remained ambiguous of its eligibility as a potential synbiotic for caries prevention. One recent in vitro study explored the possibility of L-arginine and Lactobacillus rhamnosus GG synbiotic for caries prevention. The quasi-experimental clinical study without a control arm did not explicitly mention the intervention composition and thus, its synbiotic potential remains unclear. A narrative review highlighted the potential of combining arginine (prebiotic) with arginolytic bacteria (probiotic) as a synbiotic, which appears promising for caries prevention. The eligibility of the proposed synbiotics as a true synbiotic needs to be carefully addressed. Due to a lack of controlled clinical studies on synbiotics for caries prevention, evidence on their caries-preventive potential is weak. Future studies are needed to examine the combination of amino acids (esp. arginine) with probiotics as a potential synbiotic against cariogenic pathogens.
Project description:Prebiotics and probiotics influence all pathogenic mechanisms of bacterial translocation. Used in combination, they are called synbiotics. Postoperative infective complications in patients undergoing hepatic and pancreatic surgery lead to a significant prolongation of hospital stay and increased costs. While synbiotics are considered to have beneficial effects on human health, their clinical value in surgical patients, especially in South Asia remains unclear given a paucity of applicable clinical studies. In this study we aim to assess their clinical usefulness in patients who undergo hepatic and pancreatic surgery.A prospective monocentric randomised single blind controlled trial is being conducted in patients undergoing major pancreatic resections (Whipple procedure, distal pancreatectomy, Frey procedure) and hepatic resections. Group A received a specific synbiotic composition, 5 days prior and 10 days after the surgery. Group B received a placebo. Primary study end point was the occurrence of postoperative infection during the first 30 days. Secondary outcome measures were mortality, first bowel movement, days in intensive care unit, length of hospital stay, and duration of antibiotic therapy. Side effects of probiotics were evaluated. From previous studies we assumed that perioperative synbiotics reduce the proportion of patients with infectious complications from 50% to 12%, with α of 0.05 and power 80%, the calculated sample size was 35 patients for each group with a dropout rate of 10%.This study is intended at determining the impact of perioperative synbiotic therapy on postoperative infectious complications, morbidity and mortality in patients undergoing major pancreatic and hepatic surgery.The Clinical Trials Registry of India (CTRI/2013/06/003737).