Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) - Full Text View

Purpose

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.

Condition	Intervention
Nutritional Safety	Other: Infant formula (with GOS)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants

Resource links provided by NLM:

MedlinePlus related topics: Infant and Newborn Nutrition

U.S. FDA Resources

Further study details as provided by Heinz Italia SpA:

Primary Outcome Measures:

The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever. [ Time Frame: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples. [ Time Frame: Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life. ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	February 2006
Estimated Study Completion Date:	May 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: group "S" Breast milk
No Intervention: group "A" Control Infant formula
Experimental: group "B" Infant formula supplemented with 0.4 g/100 ml of oligosaccharides	Other: Infant formula (with GOS) Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides

Detailed Description:

Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli.

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.

Eligibility

Ages Eligible for Study:	up to 15 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy infants of both sexes, born at term with natural labor or cesarean birth
Single birth
Infant born between 37th - 42th gestation week (included)
Infant with birth weight ≥ 2500 g
APGAR score after 5 minutes of life > 7
Infant born from parents of Caucasian race
Exclusive breast feeding or formula feeding within 15 days from birth.
Consensus form signed by both parents or by the legal tutor properly informed of the study.
Parents able to understand the protocol requirements and to fill out the infants Diary.

Exclusion Criteria:

Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
Diseases jeopardizing intrauterine growth.
Infant born from mother suffering from dismetabolic and/or chronic diseases.
Unknown father
Infant with parents who might not report at hospital controls or not follow the protocol.
Infant already enrolled or selected for another clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486148

Locations

Italy
"Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia
Cernusco sul Naviglio (Milan), Italy, 20063
Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia
Erba (Como), Italy, 22036
Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia
Melzo (MI), Italy, 20066
Azienda ospedaliera "San Paolo", Dipartimento di Pediatria
Milan, Italy, 20142
Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria
Milan, Italy, 20157
Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria
Milan, Italy, 20152
Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria
Piacenza, Italy, 29100

Sponsors and Collaborators

Heinz Italia SpA

Investigators

Principal Investigator:	Carlo Agostoni, Prof	Azienda Ospedaliera San Paolo
Principal Investigator:	Gian Vincenzo Zuccotti, Prof	Azienda Ospedaliera "Luigi Sacco"
Principal Investigator:	Giacomo Biasucci, Dr	Ospedale Civile "G. da Saliceto"
Principal Investigator:	Fabio Alberto Podestà, Dr	Ospedale "San Carlo Borromeo"
Principal Investigator:	Amilcare Rottoli, Dr	"Casa Pia Ospitaliera Uboldo" - Ospedale "Santa Maria delle Stelle"
Principal Investigator:	Cino Galluzzo, Dr	Ospedale "Sacra Famiglia del Fatebenefratelli"

More Information

Publications:

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. Review.

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.

Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. Review.

Macfarlane GT, Cummings JH. Probiotics and prebiotics: can regulating the activities of intestinal bacteria benefit health? BMJ. 1999 Apr 10;318(7189):999-1003. Review. 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.

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.

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.

Long SS, Swenson RM. Development of anaerobic fecal flora in healthy newborn infants. J Pediatr. 1977 Aug;91(2):298-301.

Rotimi VO, Duerden BI. The development of the bacterial flora in normal neonates. J Med Microbiol. 1981 Feb;14(1):51-62.

Orrhage K, Nord CE. Factors controlling the bacterial colonization of the intestine in breastfed infants. Acta Paediatr Suppl. 1999 Aug;88(430):47-57. Review.

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.

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.

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. Review. No abstract available.

Heine W, Mohr C, Wutzke KD. Host-microflora correlations in infant nutrition. Prog Food Nutr Sci. 1992;16(2):181-97. Review.

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. Review.

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. Review.

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.

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.

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.

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.

Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2002;(1):CD003517. Review.

Responsible Party:	Heinz Italia SpA
ClinicalTrials.gov Identifier:	NCT00486148 History of Changes
Other Study ID Numbers:	PLA-1-GOS-05
Study First Received:	June 12, 2007
Last Updated:	April 5, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Heinz Italia SpA:

Formula
Feeding
Healthy

Full
Term
Infants

ClinicalTrials.gov processed this record on June 17, 2013