Article

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

Department of Pediatrics, Turku University Hospital, Turku, Varsinais-Suomi, Finland
Journal of Pediatrics (Impact Factor: 3.74). 03/2002; 140(2):219-24. DOI: 10.1067/mpd.2002.121935
Source: PubMed

ABSTRACT We conducted a prospective, randomized 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.
Infants (n = 170) with documented cow's milk allergy were randomly 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.
An adverse reaction to the formula was confirmed by challenge in 8 patients (10%; 95% confidence interval, 4.4%-18.8%) randomly assigned to soy formula and in 2 patients (2.2%; 95% confidence interval, 0.3% to 7.8%) randomly 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).
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.

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    • "Studies excluded from the review References Description Fomonm, 1959 (15) Only four children assigned sequentially to receive a soyabean infant formula Shepard, 1960 (16) Three cases of hypothyroidism potentially associated with soya intake reported Cowan, 1969 (17) Thirty children, 2– 15 months, enrolled in a before –after study; all received a soya infant formula Ament, 1972 (18) Case report of a child with flat intestinal lesions after the use of soya Halpin, 1977 (19) Analysis of soya diets in children with persistent diarrhoea Powell, 1978 (20) Report of the use of soya and cows' milk formulas and enterocolitis Naude, 1979 (21) Preterm study with only 1 month of follow-up Zoppi, 1979 (22) Non-randomised clinical trial in thirty-nine term babies assigned to a soya flour infant formula with different amounts of protein Shenai, 1981 (23) Metabolic study in preterm babies Callenbach, 1981 (24) Aetiological studies of rickets in preterm babies Gruskay, 1982 (25) Analysis of the risk of developing atopy in 15 years Poley, 1983 (26) Electron microscopy analysis of intestinal damage induced by soya Hall, 1984 (27) Study of soya formulas for preterm babies Dagan, 1984 (28) Treatment for acute diarrhoea; short-term administration Kulkarni, 1984 (29) Case series of preterm babies with rickets fed subfortified soya formulas Sutton, 1968 (30) Treatment for acute diarrhoea; short-term administration Sampson, 1988 (31) Possible aetiological mechanisms for atopic dermatitis Nutrition Review Committee, 1988 (32) Narrative review of some articles related to soya Iyngkaran, 1988 (33) Study of the intestinal absorption effects of soya in children with diarrhoea Conway, 1989 (34) Treatment for acute diarrhoea; short-term administration Chandra, 1989 (35) Comparison of cows' milk v. soya v. casein to prevent atopic dermatitis; no report of side effects Cantani, 1990 (36) Sequential use of soya; no comparison Bock, 1990 (37) Reactions during double-blind challenge tests Willoughby, 1990 (38) Neurodevelopment study in children fed soya chloride-deficient v. soya chloride-normal formulas Malloy, 1990 (39) Follow-up study of neurodevelopment in 9-year-old children fed soya chloride-deficient v. soya chloride-normal formulas Giampietro, 1992 (40) Sensitisation to soya; no other safety parameters reported Buts, 1993 (41) Use of soya in children aged 6 months to 3 years; follow-up only for 2 months Churella, 1994 (42) Analysis of two different soya formulas with different protein contents Brown, 1994 (43) Meta-analysis of soya and lactose-free milks for acute diarrhoea Burks, 1994 (44) Study of sensitisation to soya and enterocolitis induced Chorazy, 1995 (45) Case report of a child with persistent congenital hypothyroidism while being fed soya Magnolfi, 1996 (46) Study of allergy to soya; no other safety parameters reported Essex, 1996 (12) Short narrative report on cautions about soya; not evidence based Bruno, 1997 (47) Report of allergy to soya; no other safety parameters reported Jabbar, 1997 (48) Case report of three children with hypothyroidism while being fed soya Cantani, 1997 (49) Narrative review of sensitisation to soya use; no other safety parameters reported Vanderhoof, 1997 (50) Soya in acute diarrhoea; no report on safety parameters Kuiper, 1998 (51) Basic analysis of interactions of soya with tissue receptors Businco, 1998 (52) Reported use of soya formulas for the treatment or prevention of CMPA Quak, 1998 (53) Use of soya in Asia; no safety parameters reported Irvine, 1998 (54) Twenty-five children fed a cows' milk-based infant formula and four fed a soya infant formula; measurement of genistein and daidzein levels in urine; no measurement of levels in cows' milk-fed children Setchell, 1998 (10) Observations derived from one clinical study in children and in vitro studies Lucassen, 1998 (55) Systematic review of soya for colic; no safety parameters reported Burks, 1998 (56) Soya and atopic dermatitis and food hypersensitivity; no safety parameters reported American Academy of Pediatrics, 1998 (4) Narrative review of efficacy and safety Sheehan, 1998 (57) Narrative description of potential effects; evidence in children not included Irvine, 1998 (58) Measurement of isoflavone content in food products; evidence in children not included Fayad, 1999 (59) Soya in acute diarrhoea; no report on safety parameters Zeiger, 1999 (60) Soya use and allergy to soya; no report on other safety parameters Badger, 2002 (61) Narrative discussion on experimental and adult studies; some non-systematic comments on the effects of growth and bone in children fed a soya infant formula Zoppi, 1999 (62) Narrative review of safety; no evidence-based analysis Setchell, 2000 (63) Editorial about the potential effects of isoflavones; not including evidence in children Goldman, 2001 (64) Letter to editor Barret, 2002 (65) Narrative review of basic and some clinical studies related to soya; non-systematic evidence analysis Mendez, 2002 (66) Narrative review of safety of soya formula use Ostrom, 2002 (67) Effect of palmolein added to soya or hydrolysate on Ca and PO 4 intestinal absorption Main analysis focus on palm oil; no safety parameters on soya reported Klemola, 2002 (68) Focus on the frequency of allergy to soya; no other safety parameters reported Miniello, 2003 (69) Narrative discussion on experimental and adult studies; some comments on effects on growth and bone; some non-systematic comments on effects on growth and bone in children fed a soya infant formula Tuohy, 2003 (11) Narrative review of clinical and basic papers on soya toxicity Ahn, 2003 (70) Prevalence of soya protein hypersensitivity; no other safety parameters reported Stettler, 2005 (71) Retrospective cohort study on adults to analyse the risk of obesity using different infant formulas Chen, 2004 (9) Narrative review of soya infant formulas; includes studies considered in this review Hoey, 2004 (72) Correlation between the use of soya and microbiota Giampetro, 2004 (73) Forty-eight children fed with soya; no one with precocious puberty; no control group Merritt, 2004 (74) Narrative review of soya infant formulas; includes studies considered in this review Hays, 2005 (75) Use of extensively hydrolysed formulas in allergy Berger-Achituv, 2005 (76) Indications of soya formulas; no safety issues analysed Klemola, 2005 $ 90 %, a high protein digestibility and a balanced high concentration of essential amino acids (3) . "
    [Show abstract] [Hide abstract]
    ABSTRACT: Soya-based infant formulas (SIF) containing soya flour were introduced almost 100 years ago. Modern soya formulas are used in allergy/intolerance to cows' milk-based formulas (CMF), post-infectious diarrhoea, lactose intolerance and galactosaemia, as a vegan human milk (HM) substitute, etc. The safety of SIF is still debated. In the present study, we reviewed the safety of SIF in relation to anthropometric growth, bone health (bone mineral content), immunity, cognition, and reproductive and endocrine functions. The present review includes cross-sectional, case-control, cohort studies or clinical trials that were carried out in children fed SIF compared with those fed other types of infant formulas and that measured safety. The databases that were searched included PubMed (1909 to July 2013), Embase (1988 to May 2013), LILACS (1990 to May 2011), ARTEMISA (13th edition, December 2012), Cochrane controlled trials register, Bandolier and DARE using the Cochrane methodology. Wherever possible, a meta-analysis was carried out. We found that the anthropometric patterns of children fed SIF were similar to those of children fed CMF or HM. Despite the high levels of phytates and aluminium in SIF, Hb, serum protein, Zn and Ca concentrations and bone mineral content were found to be similar to those of children fed CMF or HM. We also found the levels of genistein and daidzein to be higher in children fed SIF; however, we did not find strong evidence of a negative effect on reproductive and endocrine functions. Immune measurements and neurocognitive parameters were similar in all the feeding groups. In conclusion, modern SIF are evidence-based safety options to feed children requiring them. The patterns of growth, bone health and metabolic, reproductive, endocrine, immune and neurological functions are similar to those observed in children fed CMF or HM.
    The British journal of nutrition 02/2014; DOI:10.1017/S0007114513003942 · 3.34 Impact Factor
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    • "Studies excluded from the review References Description Fomonm, 1959 (15) Only four children assigned sequentially to receive a soyabean infant formula Shepard, 1960 (16) Three cases of hypothyroidism potentially associated with soya intake reported Cowan, 1969 (17) Thirty children, 2– 15 months, enrolled in a before –after study; all received a soya infant formula Ament, 1972 (18) Case report of a child with flat intestinal lesions after the use of soya Halpin, 1977 (19) Analysis of soya diets in children with persistent diarrhoea Powell, 1978 (20) Report of the use of soya and cows' milk formulas and enterocolitis Naude, 1979 (21) Preterm study with only 1 month of follow-up Zoppi, 1979 (22) Non-randomised clinical trial in thirty-nine term babies assigned to a soya flour infant formula with different amounts of protein Shenai, 1981 (23) Metabolic study in preterm babies Callenbach, 1981 (24) Aetiological studies of rickets in preterm babies Gruskay, 1982 (25) Analysis of the risk of developing atopy in 15 years Poley, 1983 (26) Electron microscopy analysis of intestinal damage induced by soya Hall, 1984 (27) Study of soya formulas for preterm babies Dagan, 1984 (28) Treatment for acute diarrhoea; short-term administration Kulkarni, 1984 (29) Case series of preterm babies with rickets fed subfortified soya formulas Sutton, 1968 (30) Treatment for acute diarrhoea; short-term administration Sampson, 1988 (31) Possible aetiological mechanisms for atopic dermatitis Nutrition Review Committee, 1988 (32) Narrative review of some articles related to soya Iyngkaran, 1988 (33) Study of the intestinal absorption effects of soya in children with diarrhoea Conway, 1989 (34) Treatment for acute diarrhoea; short-term administration Chandra, 1989 (35) Comparison of cows' milk v. soya v. casein to prevent atopic dermatitis; no report of side effects Cantani, 1990 (36) Sequential use of soya; no comparison Bock, 1990 (37) Reactions during double-blind challenge tests Willoughby, 1990 (38) Neurodevelopment study in children fed soya chloride-deficient v. soya chloride-normal formulas Malloy, 1990 (39) Follow-up study of neurodevelopment in 9-year-old children fed soya chloride-deficient v. soya chloride-normal formulas Giampietro, 1992 (40) Sensitisation to soya; no other safety parameters reported Buts, 1993 (41) Use of soya in children aged 6 months to 3 years; follow-up only for 2 months Churella, 1994 (42) Analysis of two different soya formulas with different protein contents Brown, 1994 (43) Meta-analysis of soya and lactose-free milks for acute diarrhoea Burks, 1994 (44) Study of sensitisation to soya and enterocolitis induced Chorazy, 1995 (45) Case report of a child with persistent congenital hypothyroidism while being fed soya Magnolfi, 1996 (46) Study of allergy to soya; no other safety parameters reported Essex, 1996 (12) Short narrative report on cautions about soya; not evidence based Bruno, 1997 (47) Report of allergy to soya; no other safety parameters reported Jabbar, 1997 (48) Case report of three children with hypothyroidism while being fed soya Cantani, 1997 (49) Narrative review of sensitisation to soya use; no other safety parameters reported Vanderhoof, 1997 (50) Soya in acute diarrhoea; no report on safety parameters Kuiper, 1998 (51) Basic analysis of interactions of soya with tissue receptors Businco, 1998 (52) Reported use of soya formulas for the treatment or prevention of CMPA Quak, 1998 (53) Use of soya in Asia; no safety parameters reported Irvine, 1998 (54) Twenty-five children fed a cows' milk-based infant formula and four fed a soya infant formula; measurement of genistein and daidzein levels in urine; no measurement of levels in cows' milk-fed children Setchell, 1998 (10) Observations derived from one clinical study in children and in vitro studies Lucassen, 1998 (55) Systematic review of soya for colic; no safety parameters reported Burks, 1998 (56) Soya and atopic dermatitis and food hypersensitivity; no safety parameters reported American Academy of Pediatrics, 1998 (4) Narrative review of efficacy and safety Sheehan, 1998 (57) Narrative description of potential effects; evidence in children not included Irvine, 1998 (58) Measurement of isoflavone content in food products; evidence in children not included Fayad, 1999 (59) Soya in acute diarrhoea; no report on safety parameters Zeiger, 1999 (60) Soya use and allergy to soya; no report on other safety parameters Badger, 2002 (61) Narrative discussion on experimental and adult studies; some non-systematic comments on the effects of growth and bone in children fed a soya infant formula Zoppi, 1999 (62) Narrative review of safety; no evidence-based analysis Setchell, 2000 (63) Editorial about the potential effects of isoflavones; not including evidence in children Goldman, 2001 (64) Letter to editor Barret, 2002 (65) Narrative review of basic and some clinical studies related to soya; non-systematic evidence analysis Mendez, 2002 (66) Narrative review of safety of soya formula use Ostrom, 2002 (67) Effect of palmolein added to soya or hydrolysate on Ca and PO 4 intestinal absorption Main analysis focus on palm oil; no safety parameters on soya reported Klemola, 2002 (68) Focus on the frequency of allergy to soya; no other safety parameters reported Miniello, 2003 (69) Narrative discussion on experimental and adult studies; some comments on effects on growth and bone; some non-systematic comments on effects on growth and bone in children fed a soya infant formula Tuohy, 2003 (11) Narrative review of clinical and basic papers on soya toxicity Ahn, 2003 (70) Prevalence of soya protein hypersensitivity; no other safety parameters reported Stettler, 2005 (71) Retrospective cohort study on adults to analyse the risk of obesity using different infant formulas Chen, 2004 (9) Narrative review of soya infant formulas; includes studies considered in this review Hoey, 2004 (72) Correlation between the use of soya and microbiota Giampetro, 2004 (73) Forty-eight children fed with soya; no one with precocious puberty; no control group Merritt, 2004 (74) Narrative review of soya infant formulas; includes studies considered in this review Hays, 2005 (75) Use of extensively hydrolysed formulas in allergy Berger-Achituv, 2005 (76) Indications of soya formulas; no safety issues analysed Klemola, 2005 $ 90 %, a high protein digestibility and a balanced high concentration of essential amino acids (3) . "
    [Show abstract] [Hide abstract]
    ABSTRACT: Soya-based infant formulas (SIF) containing soya flour were introduced almost 100 years ago. Modern soya formulas are used in allergy/intolerance to cows' milk-based formulas (CMF), post-infectious diarrhoea, lactose intolerance and galactosaemia, as a vegan human milk (HM) substitute, etc. The safety of SIF is still debated. In the present study, we reviewed the safety of SIF in relation to anthropometric growth, bone health (bone mineral content), immunity, cognition, and reproductive and endocrine functions. The present review includes cross-sectional, case-control, cohort studies or clinical trials that were carried out in children fed SIF compared with those fed other types of infant formulas and that measured safety. The databases that were searched included PubMed (1909 to July 2013), Embase (1988 to May 2013), LILACS (1990 to May 2011), ARTEMISA (13th edition, December 2012), Cochrane controlled trials register, Bandolier and DARE using the Cochrane methodology. Wherever possible, a meta-analysis was carried out. We found that the anthropometric patterns of children fed SIF were similar to those of children fed CMF or HM. Despite the high levels of phytates and aluminium in SIF, Hb, serum protein, Zn and Ca concentrations and bone mineral content were found to be similar to those of children fed CMF or HM. We also found the levels of genistein and daidzein to be higher in children fed SIF; however, we did not find strong evidence of a negative effect on reproductive and endocrine functions. Immune measurements and neurocognitive parameters were similar in all the feeding groups. In conclusion, modern SIF are evidence-based safety options to feed children requiring them. The patterns of growth, bone health and metabolic, reproductive, endocrine, immune and neurological functions are similar to those observed in children fed CMF or HM.
    British Journal Of Nutrition 02/2014; · 3.34 Impact Factor
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    • "nutritional point of view [5] [6], they are not always safe from an allergological standpoint [7] [8]. For this reason, some other mammalian milks have been proposed as alternatives to hydrolysates of cow's milk proteins and soy bean formulas. "
    [Show abstract] [Hide abstract]
    ABSTRACT: As milk represents the main source of nutrition for infants, the question of an effective human milk substitute becomes mandatory when a formula-fed baby is allergic to cows' milk proteins. In this case, formulas containing extensively hydrolysed milk proteins should be preferred, but even such a formula may cause allergic reactions in highly sensitive patients. If there is evidence of cows' milk allergy with IgE-associated symptoms, after 6 mo of age, a soy bean formula may be recommended only when tolerance to soy protein has been established by clinical challenge. In infants with allergic reactions to cows' milk proteins, even after extensive hydrolyzation, proteomic techniques coupled to immunological methods may make it possible to select other milk products that do not contain the same allergens as ordinary cow's milk. In this paper, evidence will be presented that proteomic evaluation of proteins from different mammalian species may be a suitable method of testing whether proteins from the milk of different mammalian species may be used as a substitute for untreated bovine milk.Conclusion: Proteomic evaluation of milk from different mammalian species may not only be of help when recommending suitable feeding in cases of cows' milk allergy but also gives new insight into the background to allergic reactions caused by milk proteins.
    Acta Paediatrica 01/2006; 94(12):1708-13. DOI:10.1080/08035250500434793 · 1.84 Impact Factor
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