Effects of probiotic and prebiotic on gastrointestinal motility in newborns. Prebiotic Effect of an Infant Formula Supplemented with Galacto-Oligosaccharides: Randomized Multicenter Trial A Specific Prebiotic Mixture Added to Starting Infant Formula Has Long-Lasting Bifidogenic Effects123 Physiological and Bifidogenic Effects of Prebiotic Supplements in Infant Formulae Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial. The effect of early nutritional supplementation with a mixture of probiotic, prebiotic, fiber and micronutrients in infants with acute diarrhea in Indonesia. Assessment of the safety, tolerance, and protective effect against diarrhea of infant formulas containing mixtures of probiotics or probiotics and prebiotics in a randomized controlled trial. [Randomised placebo controlled double blind study on the effect of prebiotic oligosaccharides on intestinal flora in healthy infants]. Supplementation of a bovine milk formula with an oligosaccharide mixture increases counts of faecal bifidobacteria in preterm infants Effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the intestinal microflora during the first 4 months of life. Term Infants Fed Formula Supplemented With Selected Blends of Prebiotics Grow Normally and Have Soft Stools Similar to Those Reported for Breast-fed Infants Tolerance and Safety Evaluation in a Large Cohort of Healthy Infants Fed an Innovative Prebiotic Formula: A Randomized Controlled Trial Pro- and Prebiotic Supplementation Induces a Transient Reduction in Hemoglobin Concentration in Infants Safety and Tolerance of a Probiotic Formula in Early Infancy Comparing Two Probiotic Agents: A Pilot Study Impact of maternal probiotic-supplemented dietary counselling on pregnancy outcome and prenatal and postnatal growth: a double-blind, placebo-controlled study. Effect of probiotics on the occurrence of nutrition absorption capacities in healthy children: a randomized double-blinded placebo-controlled pilot study. Effects of probiotic or prebiotic supplemented milk formulas on fecal microbiota composition of infants.
To fortify the biological role of milk formula has been suggested to use probiotics and prebiotics as functional components to mimic the effect of breast milk . The aim of this study was to evaluate the effects of prebiotic , probiotic added to a st and ard formula on gastrointestinal motility respect to placebo-formula .  Cutaneous electrogastrography ( EGG ) and ultrasound gastric emptying ( GE ) were performed in 49 preterm newborns . 17 newborns were exclusively breast-fed ; 32 were r and omly assigned to receive prebiotic-added formula ( 0.8 g/dl of a mixture from scGOS and lcFOS , ratio 9:1 ) ( 10 ) , a probiotic-added formula ( L. reuteri at dose of 1x10(8 ) colony forming units ( CFU ) per day ) ( 10 ) , a formula with placebo ( 12 ) for 30 days . No difference was seen in the nutritional parameters and no adverse events were reported . After the intervention period , the prebiotic , probiotic , and breast milk groups showed a higher percentage of EGG slow wave propagation and faster gastric half emptying time respect to placebo group ( ANOVAon ranks p<0.001 ; Dunn test vs control : prebiotic , probiotic and breast-milk vs placebo formula p<0.05 ; and ANOVA on ranks p=0.005 ; Dunn test vs control : prebiotic , probiotic and breast-milk vs placebo formula p<0.05 , respectively ) . Feeding preterm infants with a formula supplemented with prebiotics or probiotics may stimulate gastric emptying and improve maturation of the EGG activity mimicking the effect of breast milk Objective : The objective of the study was to investigate the effects of a galacto-oligosaccharides (GOS)-supplemented formula on the intestinal microbiota in healthy term infants , with a specific consideration for gastrointestinal symptoms as colic , stool frequency and consistency , regurgitation . Methods : This was a r and omized , double-blind , controlled , parallel-group clinical trial performed simultaneously by 6 centers in Italy . Three groups were considered : breastfed , formula-fed , and GOS-supplemented formula-fed infants . Formula-fed infants were r and omized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding . The nutritional composition of the 2 formulas were identical , apart from the supplemented GOS ( 0.4 g/100 mL ) in the study formula . Four different types of bacteria were evaluated in order to assess the efficacy of  GOS-supplemented formula on infants : Bifidobacterium , Lactobacillus , and Clostridium , Escherichia coli . Results : A total of 199 breastfed infants and 163 formula-fed infants were recruited . When considering stool frequency and consistency , GOS-supplemented formula presented normal and soft stools in the majority of episodes ( 89 % ) . In the supplemented group the incidence of colic was lower with respect to the control group . A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic . In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one . Conclusions : The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth , result ing in a significantly lower presence of colic There is some evidence that early colonization of the intestine affects the composition of the intestinal microbiota after weaning . In the present study , the effect of prebiotics administered from the first day of life on fecal counts of bifidobacteria and lactobacilli were studied during and after the administration of the prebiotics . In this double-blind , r and omized , placebo-controlled , explorative study , 20 newborns of hepatitis C virus-infected mothers who decided not to breast feed due to their concerns regarding their plasma viral load were r and omly assigned to either a formula with 8 g/L of a specific prebiotic mixture ( short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides , ratio 9:1 ) or a formula containing the same amount of maltodextrin ( placebo ) .  Clinical examination including anthropometric measurements , microbiological analysis of fecal sample s , and blood leukocyte population analysis were performed at birth and 3 , 6 , and 12 mo age . At the age of 12 mo , hepatitis B vaccine-specific IgG serum titers ( Hepatitis B virus surface antibodies ) were also measured . Prebiotic supplementation result ed in more fecal bifidobacteria ( P < 0.0001 ) and lactobacilli ( P = 0.0044 ) compared with the placebo group . These differences between the groups were maintained during the second half of the first year without any prebiotic supplementation . There was no influence of the different diets on anthropometric data or the measured immunological variables . The data from this small explorative study indicate that early colonization of the intestine might have long-lasting effects on the composition of the intestinal microbiota Objectives : This r and omized controlled trial involving 110 healthy neonates studied physiological and bifidogenic effects of galactooligosaccharides ( GOS ) , oligofructose , and long-chain inulin ( fructooligosaccharides , FOS ) in formula . Methods : Subjects were r and omized to Orafti Synergy1 ( 50 oligofructose:50 FOS ) 0.4 g/dL or 0.8 g/dL , GOS : FOS ( 90:10 ) 0.8 g/dL , or a st and ard formula according to Good Clinical Practice guidelines . A breast-fed group was included for comparison . Outcome parameters were weight , length , intake , stool characteristics , crying , regurgitation , vomiting , adverse events , and fecal bacterial population counts . Statistical analyses used nonparametric tests . Results : During the first month of life , weight , length , intake , and crying increased significantly in all of the groups . Regurgitation and vomiting scores were low and similar . Stool frequency decreased significantly and similarly in all of the formula groups but was lower than in the breast-fed group . All of the prebiotic groups maintained soft stools , only slightly harder than those of breast-fed infants . The st and ard group had significantly harder stools at weeks 2 and 4 compared with 1 ( P < 0.001 and P = 0.0279 ) . The total number of fecal bacteria increased in all of the prebiotic groups ( 9.82 , 9.73 , and 9.91 to 10.34 , 10.38 , and 10.37 , respectively , log10 cells/g feces , P = 0.2298 ) and more closely resembled the breast-fed pattern . Numbers of lactic acid bacteria , bacteroides , and clostridia were comparable . In the SYN1 0.8 g/dL and GOS : FOS groups , Bifidobacterium counts were significantly higher at D14 and 28 compared with D3 and were comparable with the breast-fed group . Tolerance and growth were normal . Conclusions : Stool consistency and bacterial composition of infants taking SYN1 0.8 g/dL or GOS : FOS – supplemented formula were closer to the breast-fed pattern . There was no risk of dehydration Probiotics and long-chain PUFA ( LC-PUFA ) may be beneficial supplements for infants who are not breast-fed . The aim of the present study is to evaluate the safety of an infant formula containing the LC-PUFA DHA and arachidonic acid ( AA ) and the probiotic Bifidobacterium lactis by comparing the growth rate of infants fed the supplemented and unsupplemented formulas . One hundred and forty-two healthy , term infants were enrolled in a single-centre , r and omised , double-blind , controlled , parallel-group trial , and allocated to receive either st and ard or probiotic and LC-PUFA-containing experimental formulas . The infants were fed with their assigned formulas for 7 months . The primary outcome ( weight gain ) and the secondary outcomes ( length , head circumference and formula tolerance ) were measured throughout the study . LC-PUFA status was assessed at 4 months of age and immune response to childhood vaccines was measured at 7 months of age . There was no significant difference in growth between the two groups . The 90 % CI for the difference in mean weight gain was - 0.08 , 3.1 g in the intention-to-treat population and 0.1 - 3.8 g in the per protocol population , which lay within the predefined boundaries of equivalence , - 3.9 - 3.9 . There were no significant differences in mean length and head circumference . DHA and AA concentrations were higher in infants in the experimental formula group compared with the control formula group . No influence of the supplements on the response to vaccines was observed . Growth characteristics of term infants fed the starter formula containing a probiotic and LC-PUFA were similar to st and ard formula-fed infants A r and omized double blind clinical trial was conducted to assess the efficacy of a special infant formula containing Lactobacillus rhamnosus LMG P-22799 ( probiotic : 5 x 10(8 ) CFU/100mL ) , inulin ( prebiotic : 0.15 g/100mL ) , dietary fiber ( soy polysaccharides : 0.2 g/100mL ) and increased amounts of zinc+iron ( + 0.4 and + 0.6 mg/100mL , respectively ) as active ingredients for the early dietary management of 58 Indonesian well-nourished male infants aged 3 - 12 months suffering from acute diarrhea with moderate dehydration . After adequate oral rehydration , the patients were r and omly assigned to receive either a low lactose infant formula supplemented with added precooked rice ( 1.5 g/100mL ) with the above active ingredients ( study group ) or a low lactose infant formula with added precooked rice without the above active ingredient supplement ( control group ) . No antibiotic , anti-secretory drug or antiemetic was given at all . Both study and control groups showed similar outcomes for weight gain and stool weight . The duration of diarrhea was significantly shorter in the study group than in the control group ( 1.63 versus 2.45 days ; p<0.05 ; for the study and control group respectively ) . No treatment failure or other side effects were observed during the course of the study . The present study supports the evidence for the efficacy of a special anti-diarrhea infant formula containing probiotic , prebiotic , fiber and iron+zinc after oral rehydration by shortening the duration of infantile diarrhea in developing countries . However , from the results of our study we can not discern the individual contribution of the active ingredients and also not whether they may act independent from each other or in a synergistic way BACKGROUND Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants . OBJECTIVE The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance . DESIGN In a prospect i ve , controlled , double-blind , r and omized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from < or = 2 to 16 wk of age ( treatment period ) . Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age . RESULTS Two hundred eighty-four infants were enrolled . During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d , indicating equivalent weight gain . Secondary outcomes did not show significant differences between groups during the treatment period . CONCLUSION Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well AIM Effects of supplementing prebiotic oligosaccharides to formula for healthy infants were studied in this placebo controlled , r and omised , double blind study . METHODS Ninety-seven infants were included into the study ; among them 42 breast-fed infants , 14 infants fed formula supplemented with 0.4 g/100ml oligosaccharides ( 9 to 1 mixture of galacto- and fructooligosaccharides ) and 13 infants fed control formula  were followed-up throughout the 12-week-long study period . The groups receiving formula were compared with statistical methods , whereas data of breast-fed infants served as reference values . RESULTS Infants fed the two formulae did not differ in nutrient intakes , growth , occurrence rate of feeding difficulties and atopic manifestations , or in calcium excretion . The intestinal flora did not differ between the two formula fed groups at the beginning of the study . In contrast , numbers of Bifidobacteriae were significantly higher in infants receiving the formula supplemented with prebiotic oligosaccharides both at the 14th day ( 9 x 1011 versus 5 x 1010 , colony forming units/g faeces , median , p < 0.05 ) and 28th day ( 9 x 1012 versus 5 x 1010 , p < 0.05 ) of the study . CONCLUSION In this study , supplementation of infant formula with prebiotic oligosaccharides result ed in ameliorating the difference in intestinal flora between formula fed and breast-fed healthy infants Background : The establishment of a balanced intestinal microflora which may protect against infection is desirable for the preterm infant . Objective : To investigate the effect of a preterm formula milk supplement consisting of oligosaccharides in similar proportions to human milk on the faecal flora and stool characteristics of preterm infants . Study design : To resemble the effect of human milk , an oligosaccharide mixture consisting of 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides was used to supplement a st and ard preterm formula at a concentration of 10 g/l . This supplemented formula was studied in 15 preterm infants , and the results were compared with those found in 15 infants fed a formula supplemented with maltodextrin as placebo .  A group fed fortified mother 's milk  was investigated as a reference group ( n = 12 ) . On four days during a 28 day feeding period ( 1 , 7 , 14 , and 28 ) , the faecal flora was investigated , and stool characteristics , growth , and possible side effects were recorded . Results : During the study period , the number of bifidobacteria in the group fed the oligosaccharide supplemented formula increased to the upper range of bifidobacteria counts in the reference group . The difference between the supplemented and non-supplemented groups was highly significant ( p = 0.0008 ) . The stool characteristics were also influenced by the supplement : the stool frequency after 28 days was significantly lower in the control group than in the oligosaccharide supplemented group ( p = 0.0079 ) and the reference group ( p < 0.0001 ) . Over the study period , the stool consistency in the control group became harder , but remained fairly stable in the other two groups . There was no effect of the different diets on the incidence of side effects ( crying , regurgitation , vomiting ) or on weight gain or length gain . Conclusion : Supplementing preterm formula with a mixture of galacto- and fructo-oligosaccharides at a concentration of 10 g/l stimulates the growth of bifidobacteria in the intestine and results in stool characteristics similar to those found in preterm infants fed human milk . Therefore prebiotic mixtures such as the one studied may help to improve intestinal tolerance to enteral feeding in preterm infants Adding prebiotics or probiotics to infant formula to improve the intestinal flora of formula-fed infants is considered to be a major innovation . Several companies have brought relevant formulations onto the market . However , comparative data on the effects of pre- and probiotics on the intestinal microflora of infants are not available . The present study aim ed to compare the effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the composition and metabolic activity of the intestinal microflora . Before birth , infants were r and omised and double blindly allocated to one of three formulas . The prebiotic ( GOS/FOS ) group ( n 19 ) received regular infant formula supplemented with a mixture of galacto-oligosaccharides and fructo-oligosaccharides ( 6 g/l ) . The probiotic ( Bb-12 ) group ( n 19 ) received the same formula supplemented with 6.0x10(10 ) viable cells of B. animalis per litre . The st and ard group ( n 19 ) received non-supplemented regular formula .  A group of sixty-three breast-fed infants was included as a reference group . Faecal sample s were taken at postnatal day 5 and 10 , and week 4 , 8 , 12 and 16 . Compared with the groups fed Bb-12 and st and ard formula , the GOS/FOS formula group showed higher faecal acetate ratio ( 69.7 % ( sem 2.7 ) , 69.9 % ( sem 3.9 ) and 82.2 % ( sem 5.3 ) ; P<0.05 ) and lactate concentration ( 11.3 ( sem 7.9 ) , 3.1 ( sem 2.3 ) and 34.7 ( sem 10.7 ) mmol/kg faeces ) and lower pH ( 6.6 ( sem 0.2 ) , 7.1 ( sem 0.2 ) and 5.6 ( sem 0.2 ) ; P<0.05 ) at 16 weeks . Differences in percentage of bifidobacteria between the GOS/FOS ( 59.2 % ( sem 7.7 ) ) , Bb-12 ( 52.7 % ( sem 8.0 ) ) and the st and ard ( 51.8 % ( sem 6.4 ) ) groups were not statistically significant at 16 weeks . Feeding infants GOS/FOS formula result ed in a similar effect on metabolic activity of the flora as in breast-fed infants . In the Bb-12 group , composition and metabolic activity of the flora were more similar to those of the st and ard group Objectives : The present study was design ed to evaluate the effect of 2 different combinations of prebiotic ingredients , polydextrose ( PDX ) , galactooligosaccharides ( GOS ) , and lactulose ( LOS ) , at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age . Patients and Methods : Healthy , formula-fed , term infants ( n = 226 ) were r and omly assigned to 1 of 3 study formula groups : control group ( n = 76 ) , PG4 group ( control formula supplemented with 4 g/L of a prebiotic blend , n = 74 ) , or PGL8 group ( control formula supplemented with 8 g/L of a prebiotic blend , n = 76 ) . Anthropometric measurements were taken at 14 , 30 , 60 , 90 , and 120 days of age , and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30 , 60 , 90 , and 120 days of age . Adverse events were recorded throughout the study . Results : There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point . Significant differences in stool consistency were detected among the 3 formula groups at 30 , 60 , and 90 days of age ( P < 0.001 , P = 0.025 , P = 0.004 , respectively ) , with the supplemented formula groups having looser stools than the control group . The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age ( P = 0.021 and P = 0.017 , respectively ) , but all of the groups were similar at 60 , 90 , and 120 days of age . A statistical difference was detected among the formula groups in 3 categories of adverse events : diarrhea ( control vs PG4 , 4 % vs 18 % , P = 0.008 ) , eczema ( PG4 vs control , 18 % vs 7 % , P = 0.046 ; PG4 vs PGL8 , 18 % vs 4 % , P = 0.008 ) , and irritability ( control vs PGL8 , 4 % vs 16 % , P = 0.027 ) . Conclusions : Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula . A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics Background the addition of oligosaccharides to infant formula has been shown to mimic some of the beneficial effects of human milk . The aim of the study was to assess the tolerance and safety of a formula containing an innovative mixture of oligosaccharides in early infancy . Methodology /Principal Findings this study was performed as a multi-center , r and omized , double-blind , placebo-controlled trial including healthy term infants . Infants were recruited before the age of 8 weeks , either having started with formula feeding or being fully breast-fed ( breastfeeding group ) . Formula-fed infants were r and omized to feeding with a regular formula containing a mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides ( prebiotic formula group ) or regular formula without oligosaccharides ( control formula group ) . Growth , tolerance and adverse events were assessed at 8 , 16 , 24 and 52 weeks of age . The prebiotic and control groups showed similar mean weight , length and head circumference , skin fold thicknesses , arm circumference gains and stool frequency at each study point . As far as the anthropometric parameters are concerned , the prebiotic group and the control group did not attain the values shown by the breastfeeding group at any study point . The skin fold thicknesses assessed in the breastfeeding group at 8 weeks were strikingly larger than those in formula fed infants , whereas at 52 weeks were strikingly smaller . The stool consistency in the prebiotic group was softer than in the control group at 8 , 16 and 24 weeks ( p<0.001 ) and closer to that of the breastfeeding group . There was no difference in the incidence of adverse events between the two formula groups . Conclusions our findings demonstrate the tolerability and the long term safety of a formula containing an innovative mixture of oligosaccharides in a large cohort of healthy infants . Trial Registration : drks-neu.uniklinik-freiburg.de DRKS Objectives : Regarding safety , we investigated the effect of prenatal probiotic and 6 months of pro- and prebiotic supplementation of infants on their hematologic values at 6 months and 2 years and factors affecting these values . Patients and Methods : In a prospect i ve r and omized controlled probiotic intervention trial in infants at high risk for allergy , we obtained blood sample s consecutively from 98 infants at 6 months and from 658 children at 2 years to measure hematologic values . We collected fecal sample s at 3 and 6 months to measure immunologic development by calprotectin , α-1-antitrypsin , tumor necrosis factor-α , and immunoglobulin A. Results : At 6 months , infants in the probiotic group had significantly lower hemoglobin ( Hb ) values than did the placebo group , mean ( SD ) : 119.8 g/L ( 6.3 ) versus 123.3 g/L ( 8.4 ) , P = 0.025 . Adjustment for factors that might affect Hb values ( breast-feeding duration , solid-food introduction , and sex ) , revealed no need for adjustment . A significant negative correlation emerged between Hb values at 6 months and fecal calprotectin at age 3 months r = −0.301 , P = 0.009 , which was affected neither by breast-feeding , sex , nor study group . At 2 years , hematologic values in both groups became similar . Conclusions : Probiotics cause a gut mucosal inflammation with decreased Hb values during intervention , corrected after halting the supplementation Objective : To compare the safety and tolerance of two formulas , supplemented with different probiotic agents , in early infancy . Design : Prospect i ve r and omized placebo-controlled trial . Setting : Clinics of a University Medical Center . Subjects : Full-term healthy infants aged less than 4 months . Intervention : Infants were r and omly assigned for 4 weeks to a st and ard milk-based formula supplemented with either Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( ATCC 55730 ) or a probiotics-free formula . Measures of Outcome : Growth parameters , daily characteristics of feeding , stooling and behavior , and side effects . Results : Fifty-nine infants , aged 3–65 days , were included . Subjects in all three groups were similar at entry in terms of gestational age , birth weight , sex , growth parameters and breast feeding rate prior to the study . The supplemented formulas were well accepted and did not reveal any adverse effects . A comparison of growth parameters , and variables of feeding , stooling and crying and irritability did not reveal any significant differences between groups . Conclusions : The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy , was safe , well tolerated and did not adversely affect growth , stooling habits or infant behavior The perinatal nutritional environment impacts upon the health and well-being of mother and child also in the long term . The aim of the present study was to determine the safety and efficacy of perinatal probiotic-supplemented dietary counselling by evaluating pregnancy outcome and fetal and infant growth during the 24 months ' follow-up . Altogether , 256 women were r and omised at their first trimester of pregnancy into a control and a dietary intervention group . The intervention group received intensive dietary counselling provided by a nutritionist and were further r and omised , double-blind to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) . Firstly , probiotic intervention reduced the frequency of gestational diabetes mellitus ( GDM ) ; 13 % ( diet/probiotics ) v. 36 % ( diet/placebo ) and 34 % ( control ) ; P = 0.003 . Secondly , the safety of this approach was attested by normal duration of pregnancies with no adverse events in mothers or children . No significant differences in prenatal or postnatal growth rates among the study groups were detected . Thirdly , distinctive effects of the two interventions were detected ; probiotic intervention reduced the risk of GDM and dietary intervention diminished the risk of larger birth size in affected cases ; P = 0.035 for birth weight and P = 0.028 for birth length . The results of the present study show that probiotic-supplemented perinatal dietary counselling could be a safe and cost-effective tool in addressing the metabolic epidemic . In view of the fact that birth size is a risk marker for later obesity , the present results are of significance for public health in demonstrating that this risk is modifiable OBJECTIVE Recent advances in the translational research showed that dietary nutrients have critical importance to the microbioma balance in the gastrointestinal tract . Therefore , the alteration of the intestinal microbiota in order to achieve , restore , and maintain favorable balance in the ecosystem , and the activity of microorganisms present in the gastrointestinal tract is necessary for the improved health condition of the host . The objective of this translational study was to evaluate , in a pediatric population , the efficacy and safety of prophylactic probiotics for a better nutritional absorption capacity in the view to enhance their overall health and immunity . PATIENTS AND METHODS A total of 40 pediatric patients between the ages of 14 and 18 years were enrolled in the study and divided under two categories ( treated/active group and placebo group ) . Three-time points clinical evaluations were performed : a baseline assessment ( Time 0 ) , a second evaluation at 5 weeks after the start of probiotic use ( Time 1 ) , and a final evaluation at the timeline after 10 weeks ( Time 2 ) . In the initial phase of the study , the recruited subjects underwent a panel of initial T0 clinical tests . For each of the patients , a blood sample was taken in order to evaluate the following biochemical measurements : Vitamin D , Vitamin A , Calcium , Zinc , and Iron . Moreover , an initial nutritional evaluation was carried out through which the nutritionist estimated the body composition of the subject ( weight and body mass index ) , the caloric needs and dietary behaviour of each recruited patient . RESULTS Eligible participants were r and omized into placebo ( n = 20 ) or treated/active ( n = 20 ) treatment conditions by r and om allocation using a computerized r and om number generator , ensuring all investigators remained blind to the treatment distribution . The data were compared within and between groups using statistical methods . The results confirmed that the probiotic supplementation was effective in increasing the overall blood biomarkers levels of vitamins , calcium , and mineral absorption from baseline to 10 weeks of treatment , compared with the placebo . CONCLUSIONS Probiotics may be suggested as supplements to improve biomarkers serum concentration if administered for a period of at least ≥ 5 weeks . However , further studies are required for optimal recommendations in patient treatment The aim of the study was to evaluate whether supplementation of milk-formulas with prebiotic fructo-oligosaccharides or a probiotic , Lactobacillus johnsonii La1 ( La1 ) , could modulate the composition of the fecal microbiota of formula-fed infants , compared to breastfed ( BF ) infants . Ninety infants close to 4 months of age were r and omized into one of three groups to be blindly assigned to receive for 13 weeks : a ) an infant formula ( Control ) , b ) the same formula with fructo-oligosaccharides ( Prebio ) , or c ) with La1 ( Probio ) . At the end of this period , all infants received the control formula for 2 additional weeks . Twenty-six infants , breastfed throughout the study , were recruited to form group BF . Fecal sample s were obtained upon enrolment and after 7 and 15 weeks . Bacterial population s were assessed with classical culture techniques and fluorescent in situ hybridisation ( FISH ) . Seventy-six infants completed the study . On enrolment , higher counts of Bifidobacterium and Lactobacillus and lower counts of enterobacteria were observed in BF compared to the formula-fed infants ; these differences tended to disappear at weeks 7 and 15 . No major differences for Clostridium , Bacteroides or Enterococcus were observed between the groups or along the follow up . Probio increased fecal Lactobacillus counts ( p<0.001 ) ; 88 % of the infants in this group excreted live La1 in their stools at week 7 but only 17 % at week 15 . Increased Bifidobacterium counts were observed at week 7 in the 3 formula groups , similar to BF infants . These results confirm the presence of higher counts of bifidobacteria and lactobacilli in the microbiota of BF infants compared to formula-fed infants before dietary diversification , and that La1 survives in the infant digestive tract
The administration of currently evaluated prebiotic-supplemented formulae to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Some favourable clinical effects are possible , primarily stool softening , which may be beneficial in some infants .
Currently , there is no existing robust evidence to recommend the routine use of prebiotic-supplemented formulae .
In 2011 , the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology and Nutrition systematic ally review ed published evidence related to the safety and health effects of the administration of formulae supplemented with pro- and /or prebiotics compared with unsupplemented formulae .