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"Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides.
Acta Paediatr Suppl 2003; 91(441):86-90AP

Abstract

BACKGROUND

Colic, regurgitation and constipation are common feeding problems in formula-fed infants that might benefit from dietary treatment. A formula containing fructo- and galacto-oligosaccharides, partially hydrolysed proteins, low levels of lactose and palmitic acid in the beta position and higher density has been tested to reduce the occurrence of these symptoms. The aim of this prospective study was to describe the effects of such a formula in infants with minor gastrointestinal disorders.

METHODS

An observational prospective trial involving practising Italian paediatricians was performed. Formula fed-infants up to 90 d of age with minor gastrointestinal problems such as infantile colics and/or regurgitation and/or constipation were enrolled in the study from January 2001 to May 2001. The study was completed within 14 d of treatment. On days 1, 7 and 14 the infants were visited by the paediatricians. Parents were given a structured diary to record daily episodes of colic, regurgitation and type and number of stools.

RESULTS

Of the 932 infants enrolled, 604 completed the study. Of the 214 infants with colic, 169 (79%) demonstrated a reduction in frequency of colic from 4.1 +/- 2.0 per day at the beginning of the study to 2.0 +/- 1.8 at the end of the study (I.C. 95%: 1.72-2.39; p < 0.005). A reduction in the number of episodes of colic of 1.8 per day at the beginning of the study (I.C. 95%: 1.49-2.11; p < 0.05) was recorded between day 1 and day 7, and of 0.26 (I.C. 95%: 0.15-0.37; p < 0.05) between day 7 and day 14. Of the 201 infants with regurgitation problems, 141 (70%) demonstrated a reduction of frequency of the symptoms from 4.2 +/- 2.0 per day at the beginningof the study to 2.1 +/- 2.2 at the end of the study (I.C. 95%: 1.75-2.35; p < 0.005). A reduction of 1.87 in the number of regurgitation episodes was reported between day 1 and day 7 (I.C. 95%: 1.57-2.16; p < 0.05) and of 0.18 (I.C. 95%: 0.06-0.31; p < 0.05) between day 7 and day 14. Of the 232 infants with constipation, 147 (63%) demonstrated an increase in the daily number of stools of 0.42 (I.C. 95%: 0.5-0.3; p < 0.005). An increase in stool frequency of 0.41 (I.C. 95%: 0.51-0.23; p < 0.05) was reported between day 1 and day 7, and of 0.04 (I.C. 95%: 0.22-0.14; p = ns) between day 7 and day 14. Parents' evaluation of the formula was 7.9 +/- 1.8 (score 0-10); 550 parents (91%) gave a positive judgement (score > 6). The evaluation by the paediatricians of the improvement in symptoms after the treatment was 8.2 +/- 1.5; 574 (95%) a positive effect (score > 6).

CONCLUSION

This study shows that the majority of infants followed by paediatricians for minor gastrointestinal symptoms improve within 2 wk of feeding with this new formula. Further double-blind, controlled studies are needed to confirm whether the amelioration of symptoms observed in this trial is in fact due to the new formula.

Authors+Show Affiliations

Dipartimento di Scienze Pediatriche e dell'Adolescenza, Università di Torino, Ospedale Infantile Regina Margherita, Turin, Italy. savino@pediatria.unito.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

14599049

Citation

Savino, F, et al. ""Minor" Feeding Problems During the First Months of Life: Effect of a Partially Hydrolysed Milk Formula Containing Fructo- and Galacto-oligosaccharides." Acta Paediatrica (Oslo, Norway : 1992). Supplement, vol. 91, no. 441, 2003, pp. 86-90.
Savino F, Cresi F, Maccario S, et al. "Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides. Acta Paediatr Suppl. 2003;91(441):86-90.
Savino, F., Cresi, F., Maccario, S., Cavallo, F., Dalmasso, P., Fanaro, S., ... Silvestro, L. (2003). "Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides. Acta Paediatrica (Oslo, Norway : 1992). Supplement, 91(441), pp. 86-90.
Savino F, et al. "Minor" Feeding Problems During the First Months of Life: Effect of a Partially Hydrolysed Milk Formula Containing Fructo- and Galacto-oligosaccharides. Acta Paediatr Suppl. 2003;91(441):86-90. PubMed PMID: 14599049.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - "Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides. AU - Savino,F, AU - Cresi,F, AU - Maccario,S, AU - Cavallo,F, AU - Dalmasso,P, AU - Fanaro,S, AU - Oggero,R, AU - Vigi,V, AU - Silvestro,L, PY - 2003/11/6/pubmed PY - 2004/12/22/medline PY - 2003/11/6/entrez SP - 86 EP - 90 JF - Acta paediatrica (Oslo, Norway : 1992). Supplement JO - Acta Paediatr Suppl VL - 91 IS - 441 N2 - BACKGROUND: Colic, regurgitation and constipation are common feeding problems in formula-fed infants that might benefit from dietary treatment. A formula containing fructo- and galacto-oligosaccharides, partially hydrolysed proteins, low levels of lactose and palmitic acid in the beta position and higher density has been tested to reduce the occurrence of these symptoms. The aim of this prospective study was to describe the effects of such a formula in infants with minor gastrointestinal disorders. METHODS: An observational prospective trial involving practising Italian paediatricians was performed. Formula fed-infants up to 90 d of age with minor gastrointestinal problems such as infantile colics and/or regurgitation and/or constipation were enrolled in the study from January 2001 to May 2001. The study was completed within 14 d of treatment. On days 1, 7 and 14 the infants were visited by the paediatricians. Parents were given a structured diary to record daily episodes of colic, regurgitation and type and number of stools. RESULTS: Of the 932 infants enrolled, 604 completed the study. Of the 214 infants with colic, 169 (79%) demonstrated a reduction in frequency of colic from 4.1 +/- 2.0 per day at the beginning of the study to 2.0 +/- 1.8 at the end of the study (I.C. 95%: 1.72-2.39; p < 0.005). A reduction in the number of episodes of colic of 1.8 per day at the beginning of the study (I.C. 95%: 1.49-2.11; p < 0.05) was recorded between day 1 and day 7, and of 0.26 (I.C. 95%: 0.15-0.37; p < 0.05) between day 7 and day 14. Of the 201 infants with regurgitation problems, 141 (70%) demonstrated a reduction of frequency of the symptoms from 4.2 +/- 2.0 per day at the beginningof the study to 2.1 +/- 2.2 at the end of the study (I.C. 95%: 1.75-2.35; p < 0.005). A reduction of 1.87 in the number of regurgitation episodes was reported between day 1 and day 7 (I.C. 95%: 1.57-2.16; p < 0.05) and of 0.18 (I.C. 95%: 0.06-0.31; p < 0.05) between day 7 and day 14. Of the 232 infants with constipation, 147 (63%) demonstrated an increase in the daily number of stools of 0.42 (I.C. 95%: 0.5-0.3; p < 0.005). An increase in stool frequency of 0.41 (I.C. 95%: 0.51-0.23; p < 0.05) was reported between day 1 and day 7, and of 0.04 (I.C. 95%: 0.22-0.14; p = ns) between day 7 and day 14. Parents' evaluation of the formula was 7.9 +/- 1.8 (score 0-10); 550 parents (91%) gave a positive judgement (score > 6). The evaluation by the paediatricians of the improvement in symptoms after the treatment was 8.2 +/- 1.5; 574 (95%) a positive effect (score > 6). CONCLUSION: This study shows that the majority of infants followed by paediatricians for minor gastrointestinal symptoms improve within 2 wk of feeding with this new formula. Further double-blind, controlled studies are needed to confirm whether the amelioration of symptoms observed in this trial is in fact due to the new formula. SN - 0803-5326 UR - https://www.unboundmedicine.com/medline/citation/14599049/"Minor"_feeding_problems_during_the_first_months_of_life:_effect_of_a_partially_hydrolysed_milk_formula_containing_fructo__and_galacto_oligosaccharides_ L2 - https://ClinicalTrials.gov/search/term=14599049 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -