Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high-risk children: a randomized controlled trial. Clinical Response to 2 Commonly Used Switch Formulas Occurs within 1 Day Soy allergy following early soy feeding in neonates. Allergy to soy formula and to extensively hydrolyzed whey formula in infants with cow's milk allergy: a prospective, randomized study with a follow-up to the age of 2 years. Challenge confirmation of late-onset reactions to extensively hydrolyzed formulas in infants with multiple food protein intolerance. Soy-based formula in the treatment of infantile diarrhea. The natural history of intolerance to soy and extensively hydrolyzed formula in infants with multiple food protein intolerance. Improved general health status in an unselected infant population following an allergen reduced dietary intervention programme The ZUFF-STUDY-PROGRAMME
Part I: study design and 6-month nutritional behaviour
 The effect of hydrolyzed cow's milk formula for allergy prevention in the first year of life: the German Infant Nutritional Intervention Study, a randomized double-blind trial. Effect of feeding whey hydrolysate, soy and conventional cow milk formulas on incidence of atopic disease in high risk infants. Exposure of infants to phyto-oestrogens from soy-based infant formula A randomized, single-blind and crossover study of an amino acid-based milk formula in treating young children with atopic dermatitis. Tolerance of a soy formula by infants and children. The Use of a Soy Isolate Based Formula in the Treatment of Infantile Diarrhoea Cumulative incidence of atopic disorders in high risk infants fed whey hydrolysate, soy, and conventional cow milk formulas. Five-year follow-up of high-risk infants with family history of allergy who were exclusively breast-fed or fed partial whey hydrolysate, soy, and conventional cow's milk formulas. Formula Tolerance in Postbreastfed and Exclusively Formula-fed Infants
BACKGROUND Partially hydrolyzed whey formula ( pHWF ) has been recommended for infants with a family history of allergic disease at the cessation of exclusive breast-feeding to promote oral tolerance and prevent allergic diseases . OBJECTIVE To determine whether feeding infants pHWF reduces their risk of allergic disease . METHODS A single-blind ( participant ) r and omized controlled trial was conducted to compare allergic outcomes between infants fed a conventional cow 's milk formula , a pHWF , or a soy formula . Before birth , 620 infants with a family history of allergic disease were recruited and r and omized to receive the allocated formula at cessation of breast-feeding . Skin prick tests to 6 common allergens ( milk , egg , peanut , dust mite , rye grass , and cat d and er ) were performed at 6 , 12 , and 24 months . The primary outcome was development of allergic manifestations ( eczema and food reactions ) measured 18 times in the first 2 years of life . RESULTS Follow-up was complete for 93 % ( 575/620 ) at 2 years and 80 % ( 495/620 ) at 6 or 7 years of age . There was no evidence that infants allocated to the pHWF ( odds ratio , 1.21 ; 95 % CI , 0.81 - 1.80 ) or the soy formula ( odds ratio , 1.26 ; 95 % CI , 0.84 - 1.88 ) were at a lower risk of allergic manifestations in infancy compared with conventional formula . There was also no evidence of reduced risk of skin prick test reactivity or childhood allergic disease . CONCLUSION Despite current dietary guidelines , we found no evidence to support recommending the use of pHWF at weaning for the prevention of allergic disease in high-risk infants Very fussy or extremely fussy infants were r and omized to receive :  soy-based formula ( Soy : n = 82 ) or a partially hydrolyzed cow 's milk protein ( CMP ) , low-lactose formula ( PHF : n = 77 ) in a multicenter , double-blind , r and omized , parallel , prospect i ve 28-day feeding trial . Body weight and infant formula tolerance were reported . Adverse events were recorded throughout the study . A significant reduction in mean scores of fussiness , gas , spit-up , and crying compared with baseline measures was observed in infants who received either Soy or PHF within 1 day of formula intake ; improvement in symptoms was sustained by study end . Stool consistency remained constant through day 28 in the PHF group , whereas stools in the Soy group became more firm by day 2 and did not return to pre study consistency . PHF , with a protein profile patterned more closely on human breast milk , improved symptoms of formula intolerance as well as soy-based formula UNLABELLED B ACKGROUND : Feeding neonates with humanized milk formula in maternity hospitals may increase the prevalence of  milk allergy in infants . However , prospect i ve studies of the possible allergenic effect of very early soy-based formula feeding are lacking . OBJECTIVES To assess the prevalence of soy allergy in infants fed soy-based formula in the first 3 days of life . METHODS The study group included 982 healthy full-term infants born within a 7 month period at a hospital that routinely uses soy-based formula to supplement breastfeeding .  In-hospital feeding was recorded and the parents were interviewed once monthly over the next 6 months regarding feeding practice s and clinical symptoms suggesting soy allergy in the infant . RESULTS Ninety-nine percent of the infants received soy-based formula supplement in hospital , and 33%-42 % at home . No cases of immediate allergic reaction to soy or soy-induced enterocolitis were reported . CONCLUSIONS The use of soy-based formula in the early neonatal period does not apparently increase the prevalence of soy allergy in infants followed for the next 6 months OBJECTIVES We conducted a prospect i ve , r and omized study to evaluate the cumulative incidence of allergy or other adverse reactions to soy formula and to extensively hydrolyzed formula up to the age of 2 years in infants with confirmed cow 's milk allergy . STUDY DESIGN Infants ( n = 170 ) with documented cow 's milk allergy were r and omly assigned to receive either a soy formula or an extensively hydrolyzed formula . If it was suspected that the formula caused symptoms , a double-blind , placebo-controlled challenge ( DBPCFC ) with the formula was performed . The children were followed to the age of 2 years , and soy-specific immunoglobulin E antibodies were measured at the time of diagnosis and at the ages of 1 and 2 years . RESULTS An adverse reaction to the formula was confirmed by challenge in 8 patients ( 10 % ; 95 % confidence interval , 4.4%-18.8 % ) r and omly assigned to soy formula and in 2 patients ( 2.2 % ; 95 % confidence interval , 0.3 % to 7.8 % ) r and omly assigned to extensively hydrolyzed formula .  Adverse reactions to soy were similar in IgE-associated and non-IgE-associated cow 's milk allergy ( 11 % and 9 % , respectively ) . IgE to soy was detected in only 2 infants with an adverse reaction to soy . Adverse reactions to soy formula  were more common in younger ( < 6 months ) than in older ( 6 to 12 months ) infants ( 5 of 20 vs 3 of 60 , respectively , P = .01 ) . CONCLUSIONS Soy formula was well tolerated by most infants with IgE-associated and non-IgE-associated cow 's milk allergy . Development of IgE-associated allergy to soy was rare . Soy formula can be recommended as a first-choice alternative for infants > or=6 months of age with cow 's milk allergy BACKGROUND Many infants with cow 's milk protein intolerance have adverse reactions to soy , casein and whey hydrolysate formula and to other foods . The recent development of Neocate , a hypoallergenic , nutritionally complete infant formula composed of individual amino acids and other nutrients , has enabled these infants to be stabilized . OBJECTIVE We observed the effect of food challenges in infants with reported hypersensitivity to hypoallergenic formulas . METHODS Eighteen infants ( median age , 7 1/2 months ) were given Neocate formula for 2 months and then underwent a 7-day double-blind placebo-controlled challenge with the formula previously best tolerated . RESULTS In 12 of the 18 infants irritability , vomiting , diarrhea , and /or eczema flares developed during the formula challenge . In two patients symptoms developed immediately , but in the remainder adverse reactions evolved within 7 days ( range , 4 to 7 days ) . Adverse reactions were to soy formula ( six patients ) , whey hydrolysate ( two ) , and casein hydrolysate ( four ) . When infants were 12 months of age , parents reported adverse reactions after the ingestion of other low allergen foods ( median , six ; from a panel of 10 such foods ) . CONCLUSION A group of infants with late-onset adverse reactions to soy , extensively hydrolyzed casein , and whey formulas and to other foods has been identified . Neocate formula proved to be an effective substitute formula for these patients Twenty-two infants hospitalized for severe , nonbacterial diarrhea were given at r and om either soy-protein , isolate formula or skim milk formula , following a variable period of intravenous rehydration . There was no difference in admission weight , age , duration of diarrhea , number of stools on the day prior to admission , or degree of dehydration between the two groups . The infants receiving skim milk had many more treatment failures . There was no great difference in serum electrolyte concentrations in the two feeding groups . The data suggest that during the recovery phase of gastroenteritis in young infants , a lactose-free , soy-based formula has definite advantages Infants ( n = 18 ) with intolerance to extensively hydrolyzed formulas and soy who responded to an L-amino acid-based elemental formula ( AAF ) were studied until 3 years of age . By 2 years of age most tolerated non-formula foods , and by 3 years only 3 required AAF .  Growth normalized during AAF feeding in 4 infants with failure to thrive Summary Background : The best nutritional option for newborn infants is mother 's milk . However , some newborn babies may not be exlusively breastfed during the first months of life , potentially leading to reduced overall health status and the early onset of allergic diseases in some infants . Considerable research has been devoted to the development and assessment of infant nutrition programmes , particularly to the prevention of allergies in high-risk infants . However , equal numbers of infants with and without an elevated familial risk of allergies will eventually develop allergic diseases . Therefore , optimizing nutritional programmes for the early infant population as a whole is an important – but as yet insufficiently studied – area of investigation . Moreover , although safe and effective nutrition must primarily support healthy development of the infant , few studies have evaluated the overall health benefits of nutritional interventions , but have focussed on specific allergic manifestations . In animal models , an allergen-reduced moderate whey hydrolysate formula ( pHF , Nestlé Beba HA ) induces the development of oral tolerance towards cow 's milk proteins , without inducing sensitization . In infants with a high risk for allergies , pHF formulae reduce the early onset of allergic disease during the first 5 years of life by approximately 50 % compared with a dietary regimen of unaltered proteins . At present , very little is known about the overall health benefits of such a dietary intervention on the unselected infant population as a whole . Aim of the study : The aim of our prospect i ve , controlled study was to investigate the overall health benefits of an allergen-reduced nutritional programme in a newborn infant population unselected for atopic risk factors . The population in our study was a comparable as possible to the general population of healthy newborn infants . Our study included exclusive breastfeeding , use of a moderate whey hydrolysate formula ( pHF , Nestlé Beba HA ) if infant formula was needed , and delayed introduction of low-allergenic weaning foods . The study included assessment s of compliance with the dietary programme , and evaluated nutritional habits , growth , and overall health status for 24 months . The health evaluation included allergic manifestations but die – by purpose – not define or evaluate them specifically . Part I of this paper gives results for nutritional habits during the first 6 months of life , Part II gives results for growth and general health status for the same time period , Part III will present feeding habits during the second half of the first year of life , and Part IV will present results to 24 months of age . The complete study report is published as a supplement to this journal . Methods : Nuritional assignment was to demographically comparable intervention ( Z ) or control ( FF ) cohorts according to the infant 's place of birth . In the intervention cohort ( Z , n=564 ) , the recommended dietary regimen was breastfeeding and /or the pHF formula , with no weaning food before 4 months of age . In the control cohort ( FF , n=566 ) , there was no intervention . Longitudinal diet groups , defined for 4 months , excluding dropouts and noncompliants , were exclusive breastfeeding ( eBF , Z , n=201 , FF , n=162 ) , partial breastfeeding ( pBF , Z , n=222 , FF , n=311 ) , or non-breastfeeding ( nBF , Z , n=42 , FF , n=62 ) . Imbalances between groups and cohorts in confounding factors that could influence health-related symptoms were integrated as covariates into the main analyses using logistic regression . Nutritional surveillance was carried out using continuous prospect i ve monitoring . Results : The overall rate of breastfeeding , irrespective of partial or excluive breastfeeding or the additional use of weaning foods , was similar in both cohorts at 4 and 6 months . However , from ages 3 to 6 month , significantly more Z than FF infants were excluively breastfed ( p<0.05 ) , and weaning foods were introduced at a significantly later age in Z than FF ( 22 versus 18 weeks ; p<0.0001 ) . Infants in the Z cohort received fewer different kinds of weaning foods compared with FF ( 2 versus 10 ; p<0.0001 ) . Six-month rates of dropout were very low in both groups ( Z=4.3 % , FF=1.8 % ) and compliance with the programme was excellent over the strict intervention period of 4 months ( Z=86.9 % ) until the sixth month . Conclusions : A dietary recommendation that promotes breastfeeding , includes a moderate whey hydrolysate formula ( Nestlé Beba HA ) , and delays the introduction of highly allergenic weaning foods ( an allergen-reduced dietary regimen ) significantly increases breastfeeding and delays weaning in a normal infant population without any compliance problem to the moderate hydroysate formula that is quite often seen in the eHF . The regimen was followed closely , with a high degree of compliance and a low dropout rate compared with previous allergy-prevention studies . Compliance with the dietary regimen was excellent over the 4 months of intervention and throughout the following 2 months BACKGROUND The potential of extensively or partially hydrolyzed formulas to reduce the risks for allergies is controversial . OBJECTIVE We sought to assess the preventive effect of differently hydrolyzed formulas compared with cow 's milk formula ( CMF ) in high-risk infants . METHODS Between 1995 and 1998 , 2252 infants with a hereditary risk for atopy were enrolled in the German Infant Nutritional Intervention Study and r and omly assigned at birth to one of 4 blinded formulas : CMF , partially hydrolyzed whey formula , extensively hydrolyzed whey formula , and extensively hydrolyzed casein formula ( eHF-C ) . The primary end point at 1 year of age was the presence of allergic manifestation , which was defined as atopic dermatitis ( AD ) , gastrointestinal manifestation of food allergy , allergic urticaria , or a combination of these factors . RESULTS At 12 months per protocol , analysis was performed on 945 infants exposed to study formula : 304 ( 13.5 % ) infants had left the study , 138 ( 6.1 % ) infants were excluded because of noncompliance , and 865 infants were exclusively breast-fed the first 4 months of life . The incidence of allergic manifestation was significantly reduced by using eHF-C compared with CMF ( 9 % vs 16 % ; adjusted OR , 0.51 ; 95 % CI , 0.28 - 0.92 ) , and the incidence of AD was significantly reduced by using eHF-C ( OR , 0.42 ; 95 % CI , 0.22 - 0.79 ) and partially hydrolyzed whey formula ( OR , 0.56 ; 95 % CI , 0.32 - 0.99 ) . Family history of AD was a significant risk factor and modified the preventive effect of the hydrolysates . CONCLUSIONS Prevention of allergic diseases in the first year of life is feasible by means of dietary intervention but influenced by family history of AD . The preventive effect of each hydrolyzed formula needs to be clinical ly evaluated The effect of feeding different infant formulas on incidence of atopic disease was assessed in a prospect i ve double-blind r and omized controlled trial among " high risk " infants with family history of atopy among first-degree relatives . The incidence of atopic eczema , wheezing , rhinitis , gastrointestinal symptoms , and colic was noted and serum IgE antibodies to milk were estimated . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) , conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than or equal to 4 months .  The number of infants who exited for reasons other than atopy and were excluded from analysis were 4 , 5 , 4 , and 12 in the four groups , respectively . The incidence of one or more symptoms of possible allergic etiology was five of 68 infants fed NAN/HA , 24 of 67 infants fed Similac , 25 of 68 infants fed Isomil , and 12 of 60 breast-fed infants . Among symptomatic infants , skin prick test to milk proteins was positive in four out of five infants fed NAN/HA , 16 of 24 fed Similac , 2 of 25 fed Isomil , and 7 of 12 breast-fed . IgE antibodies to milk were found in 2 of 68 , 9 of 67 , 0 of 68 , and 6 of 60 infants in the four groups , respectively . It is concluded that exclusive breast feeding for more than 4 months is partially protective against the development of atopic disease among high risk infants . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND The isoflavones genistein , daidzein , and their glycosides , found in high concentrations in soybeans and soy-protein foods , may have beneficial effects in the prevention or treatment of many hormone-dependent diseases . Because these bioactive phyto-oestrogens possess a wide range of hormonal and non-hormonal activities , it has been suggested that adverse effects may occur in infants fed soy-based formulas . METHODS To evaluate the extent of infant exposure to phyto-oestrogens from  soy formula  , the isoflavone composition of 25 r and omly selected sample s from five major br and s of commercially available soy-based infant formulas were analysed , and the plasma concentrations of genistein and daidzein , and the intestinally derived metabolite , equol , were compared in 4-month-old infants fed exclusively soy-based infant formula ( n = 7 ) , cow-milk formula ( n = 7 ) , or human breast-milk ( n = 7 ) . FINDINGS All of the soy formulas contained mainly glycosides of genistein and daidzein , and the total isoflavone content was similar among the five formulas analysed and was related to the proportion of soy isolate used in their manufacture . From the concentrations of isoflavones in these formulas ( means 32 - 47 micrograms/mL ) , the typical daily volume of milk consumed , and average bodyweight , a 4-month-old infant fed soy formula would be exposed to 28 - 47 per day , or about 4.5 - 8.0 mg/kg bodyweight per day , of total isoflavones . Mean ( SD ) plasma concentrations of genistein and daidzein in the seven infants fed soy-based formulas were 684 ( 443 ) ng/mL and 295 ( 60 ) ng/mL , respectively , which was significantly greater ( p < 0.05 ) than in the infants fed either cow-milk formulas ( 3.2 [ 0.7 ] and 2.1 [ 0.3 ] ng/mL ) , or human breast-milk ( 2.8 [ 0.7 ] and 1.4 [ 0.1 ] ng/mL ) , and an order of magnitude higher per bodyweight than typical plasma concentrations of adults consuming soy foods . INTERPRETATION The daily exposure of infants to isoflavones in soy infant-formulas is 6 - 11 fold higher on a bodyweight basis than the dose that has hormonal effects in adults consuming soy foods . Circulating concentrations of isoflavones in the seven infants fed soy-based formula were 13000 - 22000 times higher than plasma oestradiol concentrations in early life , and may be sufficient to exert biological effects , whereas the contribution of isoflavones from breast-milk and cow-milk is negligible Cow 's milk and soy protein allergies are commonly associated with atopic dermatitis ( AD ) in young children .  Amino acid (AA)-based elemental milk formula may improve AD control in these patients . This study investigates the efficacy of AA-based formula in treating young AD patients irrespective of their food allergy status . AD patients younger than 3 yr old were eligible . Sensitization to food allergens was ascertained by skin prick tests and allergen-specific immunoglobulin E ( IgE ) assay . Patients were then r and omly allocated to take either active treatment or pre-existing formulae ( placebo ) for 6 wk . They were allowed a 6-wk washout period before crossed over to the other intervention for another 6 wk . Fifteen AD patients , with median ( interquartile range , IQR ) age of 1.4 ( 0.6 - 2.6 ) yr , were recruited . Their median ( IQR ) SCORAD score was 23.9 ( 10.5 - 29.7 ) . Seven of them were sensitized to cow 's milk or soybean . Among 11 patients who completed the study , the median changes for all scores and urinary eosinophil protein X ( EPX ) concentration were not statistically significant . There was also no evidence of carry-over effects for SCORAD and its various components and global health score , except for urinary EPX concentration ( p = 0.05 ) . Our results do not support the use of AA-based elemental milk formula in treating young children with AD irrespective of their food allergy status For a minimum of one month ( mean , 54 days ) , 287 infants and children less than 8 years of age were fed an isolated soy-protein formula . Prior to entry into the study , a cow 's milk formula was being fed to 71 % , a soy formula to 9 % , and cow 's milk or other formulas to 20 % . Intolerance to cow 's milk was reported in 35 % of the patients , symptoms indicative of cow 's milk intolerance in 23 % , diarrhea or gastroenteritis in 18 % , a family history of allergy in 13 % , and insufficient weight gain , intolerance to other formulas , or constipation in 11 % . The patients showed normal increases in weight and length during the study . A significant decrease in the following symptoms were reported in the patients from before to after treatment : abdominal cramps , bloating or gas , colic , diarrhea , fussiness , rashes or eczema , spitting up , waking up crying at night , wheezing , and vomiting . It is concluded that , while receiving soy formula , infants and children continued to thrive normally and that the formula was well tolerated . After receiving soy formula , the frequency of undesirable feeding-related symptoms was reduced in the majority of infants and children Lactose intolerance interferes with the recovery phase in patients with severe diarrhoea . A controlled comparison of a lactose-free soy isolate formula ( Isomil ® ) and a st and ard cow 's milk-based formula in 112 infants with severe diarrhoea showed a significant advantage for the lactose-free formula .  All the infants were dehydrated on admission and required initial intravenous therapy . The response rate in the two groups was , respectively , 93 % and 75 % A recent increase in the prevalence of atopic disorders and the enormous costs of management of atopic patients have prompted attempts at prevention . We have examined the effect of exclusive breast feeding and of feeding different infant formulas on incidence of atopic disease in a prospect i ve r and omized controlled study . Seventy-two infants were recruited into each of the following groups : cow milk whey hydrolysate formula ( NAN/HA ) conventional cow milk formula ( Similac ) , soy-based formula ( Isomil ) , and exclusive breast feeding for greater than 4 months .  The cumulative incidence of atopic eczema , recurrent wheezing , rhinitis , gastrointestinal symptoms , and colic were noted . Skin prick tests and radioallergosorbent tests for IgE antibodies to milk and soy were performed . At 12 and 18 months of age , the incidence of atopic eczema as also that of all atopic symptoms was significantly lower and similar in the breast-fed and whey hydrolysate groups , compared with the cow milk and soy formula groups . IgE antibodies were detected more often in the cow milk and soy formula groups , especially the former . Among symptomatic infants , fewer skin positive prick tests were seen in the soy group compared with the cow milk group . Our observations show that among infants at high risk of developing atopic disease because of positive family history , exclusive breast feeding or whey hydrolysate formula is associated with a lower incidence and thus a delay in the occurrence of allergic disorders compared with groups fed conventional cow milk or soy formulas BACKGROUND Allergy is a common cause of illness . The effect of feeding different infant formulas on the incidence of atopic disease and food allergy was assessed in a prospect i ve r and omized double-blind study of high-risk infants with a family history of atopy . METHODS 216 high-risk infants whose mothers had elected not to breast-feed were r and omized to receive exclusively a partial whey hydrolysate formula or a conventional cow 's milk formula or a soy formula until 6 months of age . Seventy-two high risk infants breast-fed for > or = 4 months were also studied . RESULTS Follow-up until 5 years of age showed a significant lowering in the cumulative incidence of atopic disease in the breast-fed ( odds ratio 0.422 [ 0.200 - 0.891 ] ) and the whey hydrolysate ( odds ratio 0.322 [ 0.159 - 0.653 ) groups , compared with the conventional cow 's milk group . Soy formula was not effective ( odds ratio 0.759 [ 0.384 - 1.501 ] ) . The occurrence of both eczema and asthma was lowest in the breast-fed and whey hydrolysate groups and was comparable in the cow 's milk and soy groups . Similar significant differences were noted in the 18 - 60 month period prevalence of eczema and asthma . Eczema was less severe in the whey hydrolysate group compared with the other groups . Double-blind placebo-controlled food challenges showed a lower prevalence of food allergy in the whey hydrolysate group compared with the other formula groups . CONCLUSIONS Exclusive breast-feeding or feeding with a partial whey hydrolysate formula is associated with lower incidence of atopic disease and food allergy . This is a cost-effective approach to the prevention of allergic disease in children Objective . Perceived intolerance to infant formula is a frequently reported reason for formula switching . Formula intolerance may be related to perceived symptoms of constipation , fussiness , abdominal cramps , and excessive spit-up or vomit . Commercially available formulas differ from each other in processing and in sources and levels of protein , lipids , and micronutrients . These differences may affect tolerance . The objective of this article was to compare the tolerance of two commercially available powder infant formulas that differ in composition . Measures of tolerance in exclusively breastfed infants weaned to an infant formula and exclusively formula-fed infants were evaluated . Methods . Two clinical studies were conducted . In study 1 , 82 healthy , full-term infants who were exclusively breastfed at the time of enrollment were  r and omized at weaning to formula A ( commercially available Similac With Iron Powder ) or formula B ( previously available Enfamil With Iron Powder ) . Parents completed daily records of tolerance during exclusive breast milk feeding , during the weaning period , and for a 2-week exclusive formula-feeding period . In study 2 , 87 healthy , full-term infants who were exclusively formula-fed at the time of study enrollment ( by 2 weeks of age ) were fed a st and ard cow milk-based formula ( previously commercially available Similac With Iron Powder ) and then r and omized to receive formula A or B for a 2-week period . Parents completed daily records of tolerance throughout the study . Formula A was a cow milk-based formula with a whey : casein ratio of 48:52 and a fat blend of 42 % high-oleic safflower , 30 % coconut , and 28 % soy oils . Formula B was a cow milk-based formula with a whey : casein ratio of 60:40 and a fat blend of 45 % palm olein , 20 % soy , 20 % coconut , and 15 % high-oleic sunflower oils . Both formulas had lactose as the source of carbohydrate and contained 12 mg of iron per liter . Only formula A contained nucleotides at the time of the study . Measures of tolerance included volume of each formula feeding , occurrences of spit-up and /or vomit , and the color ( yellow , green , brown , or black ) and consistency ( water , loose/mushy , soft , formed , or hard ) of each stool . Results . In both studies , volume of formula intake , weight gain , and incidence of spit-up or vomit did not differ between feeding groups . In study 1 , stool frequency decreased significantly from the exclusive breast milk period to weaning . Stools also became firmer as infants moved from breast milk to weaning and to exclusive formula feeding . When formula was introduced into the diet , stools became less yellow and more green . Infants weaned to formula B had less frequent stools , fewer brown stools , and more yellow stools than did infants fed formula A. In both studies , infants fed formula B experienced significantly firmer stools than did those fed formula A. Conclusions . The present clinical studies indicate that the composition and /or processing of milk-based powder iron-fortified infant formulas affect stool characteristics experienced by infants . The inclusion of palm olein oil in formula B may be the reason for the observed differences in stool characteristics . Palm olein is used in infant formulas to provide palmitic acid at a level similar to that found in breast milk . However , palmitic acid from palm olein is arranged differently from that in breast milk triglyceride and is poorly absorbed . Unabsorbed palmitic acid tends to react with calcium to form insoluble soaps , and the level of these soaps is correlated with stool hardness . The pattern of softer stools and greater frequency of stooling associated with formula A is similar to the stool pattern in the exclusively breastfed infant . Thus , the use of formula A may ease the transition from breast milk to formula feeding and ameliorate parents ' perception that constipation is associated with iron-fortified formula
They support SIF 's  efficacy in the management of cow 's milk allergy and infant 's digestive tolerance , as well as its low cross allergy compared to cow 's milk and other formulas .
There is also evidence that demonstrates that SIFs have important advantages in terms of cost-benefit , palatability and effects on the intestinal microbiota , compared to other formulas .
Conclusions Although evidence to recommend its use in functional digestive disorders is limited , SIFs have an adequate safety profile and are still a valid option for infant feeding
Background Soy infant formulas ( SIF ) have long been used as an alternative for infants with special nutritional requirements .
However , the medical indications for their use , their allergenicity , safety and efficacy are still controversial .
Objective To present recommendations for the use of SIF based on the existing literature .