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

NCT00486148 | Completed

• 1 other identifier: PLA-1-GOS-05
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Nutritional Safety

Keywords

Formula; Feeding; Healthy; Full; Term; Infants

Outcome Measures

Primary Outcomes (1)

• The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.

  Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.

Secondary Outcomes (1)

• The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples.

  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.

Study Arms (3)

group "S"

NO INTERVENTION

Breast milk

group "A"

NO INTERVENTION

Control Infant formula

group "B"

EXPERIMENTAL

Infant formula supplemented with 0.4 g/100 ml of oligosaccharides

Other: Infant formula (with GOS)

Interventions

Infant formula (with GOS) OTHER

Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides

group "B"

Eligibility Criteria

• Age: 1 Day - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heinz Italia SpA: lead

Study Sites (7)

"Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia

Cernusco Sul Naviglio (Milan), 20063, Italy

Location

Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia

Erba (Como), 22036, Italy

Location

Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia

Melzo (MI), 20066, Italy

Location

Azienda ospedaliera "San Paolo", Dipartimento di Pediatria

Milan, 20142, Italy

Location

Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria

Milan, 20152, Italy

Location

Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria

Milan, 20157, Italy

Location

Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria

Piacenza, 29100, Italy

Location

Related Publications (21)

• 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.

  PMID: 12010580 BACKGROUND

• 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.

  PMID: 15572882 BACKGROUND

• 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.

  PMID: 7782892 BACKGROUND

• 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.

  PMID: 10195977 BACKGROUND

• 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.

  PMID: 11964956 BACKGROUND

• 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.

  PMID: 11978748 BACKGROUND

• 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.

  PMID: 12604972 BACKGROUND

• 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.

  PMID: 874690 BACKGROUND

• 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.

  PMID: 7463467 BACKGROUND

• 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.

  PMID: 10569223 BACKGROUND

• 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.

  PMID: 6513816 BACKGROUND

• 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.

  PMID: 3984727 BACKGROUND

• 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.

  PMID: 12026013 BACKGROUND

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

  PMID: 1496120 BACKGROUND

• 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.

  PMID: 10394490 BACKGROUND

• 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.

  PMID: 10940350 BACKGROUND

• 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.

  PMID: 10837303 BACKGROUND

• 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.

  PMID: 10697138 BACKGROUND

• 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.

  PMID: 15188977 BACKGROUND

• 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.

  PMID: 2105113 BACKGROUND

• Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2002;(1):CD003517. doi: 10.1002/14651858.CD003517.

  PMID: 11869667 BACKGROUND

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• 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"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: February 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2013
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

IT (7)