Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)
NCT ID: NCT00486148
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2006-02-28
2013-06-30
Brief Summary
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Detailed Description
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Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.
Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.
However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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group "S"
Breast milk
No interventions assigned to this group
group "A"
Control Infant formula
No interventions assigned to this group
group "B"
Infant formula supplemented with 0.4 g/100 ml of oligosaccharides
Infant formula (with GOS)
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
Interventions
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Infant formula (with GOS)
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
Eligibility Criteria
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Inclusion Criteria
2. Single birth
3. Infant born between 37th - 42th gestation week (included)
4. Infant with birth weight ≥ 2500 g
5. APGAR score after 5 minutes of life \> 7
6. Infant born from parents of Caucasian race
7. Exclusive breast feeding or formula feeding within 15 days from birth.
8. Consensus form signed by both parents or by the legal tutor properly informed of the study.
9. Parents able to understand the protocol requirements and to fill out the infants Diary.
Exclusion Criteria
2. Diseases jeopardizing intrauterine growth.
3. Infant born from mother suffering from dismetabolic and/or chronic diseases.
4. Unknown father
5. Infant with parents who might not report at hospital controls or not follow the protocol.
6. Infant already enrolled or selected for another clinical trial.
1 Day
15 Days
ALL
No
Sponsors
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Heinz Italia SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Carlo Agostoni, Prof
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera San Paolo
Gian Vincenzo Zuccotti, Prof
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera "Luigi Sacco"
Giacomo Biasucci, Dr
Role: PRINCIPAL_INVESTIGATOR
Ospedale Civile "G. da Saliceto"
Fabio Alberto Podestà, Dr
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Carlo Borromeo
Amilcare Rottoli, Dr
Role: PRINCIPAL_INVESTIGATOR
"Casa Pia Ospitaliera Uboldo" - Ospedale "Santa Maria delle Stelle"
Cino Galluzzo, Dr
Role: PRINCIPAL_INVESTIGATOR
Ospedale "Sacra Famiglia del Fatebenefratelli"
Locations
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"Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia
Cernusco Sul Naviglio (Milan), , Italy
Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia
Erba (Como), , Italy
Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia
Melzo (MI), , Italy
Azienda ospedaliera "San Paolo", Dipartimento di Pediatria
Milan, , Italy
Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria
Milan, , Italy
Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria
Milan, , Italy
Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria
Piacenza, , Italy
Countries
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References
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Mountzouris KC, McCartney AL, Gibson GR. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002 May;87(5):405-20. doi: 10.1079/BJNBJN2002563.
Agostoni C, Axelsson I, Goulet O, Koletzko B, Michaelsen KF, Puntis JW, Rigo J, Shamir R, Szajewska H, Turck D; ESPGHAN Committee on Nutrition. Prebiotic oligosaccharides in dietetic products for infants: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2004 Nov;39(5):465-73. doi: 10.1097/00005176-200411000-00003.
Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.
Macfarlane GT, Cummings JH. Probiotics and prebiotics: can regulating the activities of intestinal bacteria benefit health? BMJ. 1999 Apr 10;318(7189):999-1003. doi: 10.1136/bmj.318.7189.999. No abstract available.
Moro G, Minoli I, Mosca M, Fanaro S, Jelinek J, Stahl B, Boehm G. Dosage-related bifidogenic effects of galacto- and fructooligosaccharides in formula-fed term infants. J Pediatr Gastroenterol Nutr. 2002 Mar;34(3):291-5. doi: 10.1097/00005176-200203000-00014.
Boehm G, Lidestri M, Casetta P, Jelinek J, Negretti F, Stahl B, Marini A. Supplementation of a bovine milk formula with an oligosaccharide mixture increases counts of faecal bifidobacteria in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 May;86(3):F178-81. doi: 10.1136/fn.86.3.f178.
Schmelzle H, Wirth S, Skopnik H, Radke M, Knol J, Bockler HM, Bronstrup A, Wells J, Fusch C. Randomized double-blind study of the nutritional efficacy and bifidogenicity of a new infant formula containing partially hydrolyzed protein, a high beta-palmitic acid level, and nondigestible oligosaccharides. J Pediatr Gastroenterol Nutr. 2003 Mar;36(3):343-51. doi: 10.1097/00005176-200303000-00008.
Long SS, Swenson RM. Development of anaerobic fecal flora in healthy newborn infants. J Pediatr. 1977 Aug;91(2):298-301. doi: 10.1016/s0022-3476(77)80836-6.
Rotimi VO, Duerden BI. The development of the bacterial flora in normal neonates. J Med Microbiol. 1981 Feb;14(1):51-62. doi: 10.1099/00222615-14-1-51.
Orrhage K, Nord CE. Factors controlling the bacterial colonization of the intestine in breastfed infants. Acta Paediatr Suppl. 1999 Aug;88(430):47-57. doi: 10.1111/j.1651-2227.1999.tb01300.x.
Benno Y, Sawada K, Mitsuoka T. The intestinal microflora of infants: composition of fecal flora in breast-fed and bottle-fed infants. Microbiol Immunol. 1984;28(9):975-86. doi: 10.1111/j.1348-0421.1984.tb00754.x.
Lundequist B, Nord CE, Winberg J. The composition of the faecal microflora in breastfed and bottle fed infants from birth to eight weeks. Acta Paediatr Scand. 1985 Jan;74(1):45-51. doi: 10.1111/j.1651-2227.1985.tb10919.x.
Howie PW. Protective effect of breastfeeding against infection in the first and second six months of life. Adv Exp Med Biol. 2002;503:141-7. doi: 10.1007/978-1-4615-0559-4_16. No abstract available.
Heine W, Mohr C, Wutzke KD. Host-microflora correlations in infant nutrition. Prog Food Nutr Sci. 1992;16(2):181-97.
Kunz C, Rodriguez-Palmero M, Koletzko B, Jensen R. Nutritional and biochemical properties of human milk, Part I: General aspects, proteins, and carbohydrates. Clin Perinatol. 1999 Jun;26(2):307-33.
Kunz C, Rudloff S, Baier W, Klein N, Strobel S. Oligosaccharides in human milk: structural, functional, and metabolic aspects. Annu Rev Nutr. 2000;20:699-722. doi: 10.1146/annurev.nutr.20.1.699.
Engfer MB, Stahl B, Finke B, Sawatzki G, Daniel H. Human milk oligosaccharides are resistant to enzymatic hydrolysis in the upper gastrointestinal tract. Am J Clin Nutr. 2000 Jun;71(6):1589-96. doi: 10.1093/ajcn/71.6.1589.
Erney RM, Malone WT, Skelding MB, Marcon AA, Kleman-Leyer KM, O'Ryan ML, Ruiz-Palacios G, Hilty MD, Pickering LK, Prieto PA. Variability of human milk neutral oligosaccharides in a diverse population. J Pediatr Gastroenterol Nutr. 2000 Feb;30(2):181-92. doi: 10.1097/00005176-200002000-00016.
Giovannini M, Riva E, Banderali G, Scaglioni S, Veehof SH, Sala M, Radaelli G, Agostoni C. Feeding practices of infants through the first year of life in Italy. Acta Paediatr. 2004 Apr;93(4):492-7. doi: 10.1080/08035250410025591.
Howie PW, Forsyth JS, Ogston SA, Clark A, Florey CD. Protective effect of breast feeding against infection. BMJ. 1990 Jan 6;300(6716):11-6. doi: 10.1136/bmj.300.6716.11.
Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2002;(1):CD003517. doi: 10.1002/14651858.CD003517.
Other Identifiers
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PLA-1-GOS-05
Identifier Type: -
Identifier Source: org_study_id
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