Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Formula Feeding of Healthy Full Term Infants Clinical Trial

Official title:

Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197365
• Other study ID #: PLA-LENI-09
• Status: Completed
• Phase: N/A
• First received: September 7, 2010
• Last updated: February 2, 2015
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Heinz Italia SpA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.

Description:

Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.

New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.

The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.

The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

Inclusion Criteria:

• Infants of both sexes born to natural or cesarean delivery

• Gestational age between 37 and 42 completed weeks

• Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts

• Single birth

• Caucasian parents

• Infants being exclusively formula-fed by the 21st day of life

Exclusion Criteria:

• Infants with genetic and/or congenital diseases

• Infants receiving antibiotic therapy

• Infants with neonatal diseases requiring hospitalisation for longer than 7 days

• Infants at risk for atopy and/or having familial history for atopy

• Mothers with metabolic or chronic diseases

• Infant selected for another clinical study

• Parents refusing to sign a written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Formula Feeding of Healthy Full Term Infants

Intervention

Other:
• Infant formula with GOS, beta-palmitate, acidified milk
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
• Standard infant formula without functional ingredients
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients

Locations

Country	Name	City	State
Italy	Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva	Pavia	PV

Sponsors (4)

Lead Sponsor	Collaborator
Heinz Italia SpA	Advanced Analytical Technologies, Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi), IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (25)

Aggett PJ, Agostini C, Goulet O, Hernell O, Koletzko B, Lafeber HL, Michaelsen KF, Rigo J, Weaver LT; European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. The nutritional and safety assessment of breast milk substitutes and other dietary products for infants: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2001 Mar;32(3):256-8. — View Citation

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. — View Citation

Ben XM, Li J, Feng ZT, Shi SY, Lu YD, Chen R, Zhou XY. Low level of galacto-oligosaccharide in infant formula stimulates growth of intestinal Bifidobacteria and Lactobacilli. World J Gastroenterol. 2008 Nov 14;14(42):6564-8. — View Citation

Ben XM, Zhou XY, Zhao WH, Yu WL, Pan W, Zhang WL, Wu SM, Van Beusekom CM, Schaafsma A. Supplementation of milk formula with galacto-oligosaccharides improves intestinal micro-flora and fermentation in term infants. Chin Med J (Engl). 2004 Jun;117(6):927-31. — View Citation

Billeaud C, Guillet J, Sandler B. Gastric emptying in infants with or without gastro-oesophageal reflux according to the type of milk. Eur J Clin Nutr. 1990 Aug;44(8):577-83. — View Citation

Brunser O, Araya M, Espinoza J, Guesry PR, Secretin MC, Pacheco I. Effect of an acidified milk on diarrhoea and the carrier state in infants of low socio-economic stratum. Acta Paediatr Scand. 1989 Mar;78(2):259-64. — View Citation

Carnielli VP, Luijendijk IH, van Beek RH, Boerma GJ, Degenhart HJ, Sauer PJ. Effect of dietary triacylglycerol fatty acid positional distribution on plasma lipid classes and their fatty acid composition in preterm infants. Am J Clin Nutr. 1995 Oct;62(4):776-81. — View Citation

Carnielli VP, Luijendijk IH, van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Feeding premature newborn infants palmitic acid in amounts and stereoisomeric position similar to that of human milk: effects on fat and mineral balance. Am J Clin Nutr. 1995 May;61(5):1037-42. — View Citation

Carnielli VP, Luijendijk IH, Van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Structural position and amount of palmitic acid in infant formulas: effects on fat, fatty acid, and mineral balance. J Pediatr Gastroenterol Nutr. 1996 Dec;23(5):553-60. — View Citation

Carver JD. Advances in nutritional modifications of infant formulas. Am J Clin Nutr. 2003 Jun;77(6):1550S-1554S. Review. — View Citation

Fanaro S, Marten B, Bagna R, Vigi V, Fabris C, Peña-Quintana L, Argüelles F, Scholz-Ahrens KE, Sawatzki G, Zelenka R, Schrezenmeir J, de Vrese M, Bertino E. Galacto-oligosaccharides are bifidogenic and safe at weaning: a double-blind randomized multicenter study. J Pediatr Gastroenterol Nutr. 2009 Jan;48(1):82-8. doi: 10.1097/MPG.0b013e31817b6dd2. — View Citation

Kennedy K, Fewtrell MS, Morley R, Abbott R, Quinlan PT, Wells JC, Bindels JG, Lucas A. Double-blind, randomized trial of a synthetic triacylglycerol in formula-fed term infants: effects on stool biochemistry, stool characteristics, and bone mineralization. Am J Clin Nutr. 1999 Nov;70(5):920-7. — View Citation

López-López A, Castellote-Bargalló AI, Campoy-Folgoso C, Rivero-Urgël M, Tormo-Carnicé R, Infante-Pina D, López-Sabater MC. The influence of dietary palmitic acid triacylglyceride position on the fatty acid, calcium and magnesium contents of at term newborn faeces. Early Hum Dev. 2001 Nov;65 Suppl:S83-94. — View Citation

Lucas A, Quinlan P, Abrams S, Ryan S, Meah S, Lucas PJ. Randomised controlled trial of a synthetic triglyceride milk formula for preterm infants. Arch Dis Child Fetal Neonatal Ed. 1997 Nov;77(3):F178-84. — View Citation

Lucas A, St James-Roberts I. Crying, fussing and colic behaviour in breast- and bottle-fed infants. Early Hum Dev. 1998 Nov;53(1):9-18. — View Citation

Mackie RI, Sghir A, Gaskins HR. Developmental microbial ecology of the neonatal gastrointestinal tract. Am J Clin Nutr. 1999 May;69(5):1035S-1045S. Review. — View Citation

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. — View Citation

Mullié C, Yazourh A, Thibault H, Odou MF, Singer E, Kalach N, Kremp O, Romond MB. Increased poliovirus-specific intestinal antibody response coincides with promotion of Bifidobacterium longum-infantis and Bifidobacterium breve in infants: a randomized, double-blind, placebo-controlled trial. Pediatr Res. 2004 Nov;56(5):791-5. Epub 2004 Sep 3. — View Citation

Nelson CM, Innis SM. Plasma lipoprotein fatty acids are altered by the positional distribution of fatty acids in infant formula triacylglycerols and human milk. Am J Clin Nutr. 1999 Jul;70(1):62-9. — View Citation

Quinlan PT, Lockton S, Irwin J, Lucas AL. The relationship between stool hardness and stool composition in breast- and formula-fed infants. J Pediatr Gastroenterol Nutr. 1995 Jan;20(1):81-90. — View Citation

Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9. — View Citation

Thibault H, Aubert-Jacquin C, Goulet O. Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):147-52. — View Citation

Tlaskalová-Hogenová H, Stepánková R, Hudcovic T, Tucková L, Cukrowska B, Lodinová-Zádníková R, Kozáková H, Rossmann P, Bártová J, Sokol D, Funda DP, Borovská D, Reháková Z, Sinkora J, Hofman J, Drastich P, Kokesová A. Commensal bacteria (normal microflora), mucosal immunity and chronic inflammatory and autoimmune diseases. Immunol Lett. 2004 May 15;93(2-3):97-108. Review. — View Citation

World Health Organization. Nutrient adequacy of exclusive breastfeeding for the term infant during the first six months of life. Geneva, 2002.

Zoppi G, Cinquetti M, Luciano A, Benini A, Muner A, Bertazzoni Minelli E. The intestinal ecosystem in chronic functional constipation. Acta Paediatr. 1998 Aug;87(8):836-41. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms	Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.	Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.	No
Secondary	Immune-modulatory activity	Quantification of salivary IgA	At enrolment, after 60 and 135 days of life	No
Secondary	Prebiotic effect	Microbiological analysis of feces	At enrolment and after 135 days of life	No