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| Name | Class |
|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
| Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi) | UNKNOWN |
| Advanced Analytical Technologies | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STUDY GROUP | Experimental | 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 |
|
| CONTROL GROUP | Other | Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula with GOS, beta-palmitate, acidified milk | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune-modulatory activity | Quantification of salivary IgA | At enrolment, after 60 and 135 days of life |
| Prebiotic effect | Microbiological analysis of feces |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Stronati, Prof. | FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva | Pavia | PV | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11345171 | Background | 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. doi: 10.1097/00005176-200103000-00004. No abstract available. | |
| 12812153 |
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|
| Standard infant formula without functional ingredients | Other | Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients |
|
| At enrolment and after 135 days of life |
| Background |
| Carver JD. Advances in nutritional modifications of infant formulas. Am J Clin Nutr. 2003 Jun;77(6):1550S-1554S. doi: 10.1093/ajcn/77.6.1550S. |
| 15572882 | 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. |
| 2929349 | Background | 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. doi: 10.1111/j.1651-2227.1989.tb11066.x. |
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| 10193923 | Background | 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. doi: 10.1016/s0378-3782(98)00032-2. |
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| 7733025 | Background | 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. doi: 10.1093/ajcn/61.4.1037. |
| 7572708 | Background | 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. doi: 10.1093/ajcn/62.4.776. |
| 8985844 | Background | 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. doi: 10.1097/00005176-199612000-00007. |
| 9462186 | Background | 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. doi: 10.1136/fn.77.3.f178. |
| 10539755 | Background | 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. doi: 10.1093/ajcn/70.5.920. |
| 11755039 | Background | Lopez-Lopez A, Castellote-Bargallo AI, Campoy-Folgoso C, Rivero-Urgel M, Tormo-Carnice R, Infante-Pina D, Lopez-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. doi: 10.1016/s0378-3782(01)00210-9. |
| 10393140 | Background | 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. doi: 10.1093/ajcn/70.1.62. |
| 10232646 | Background | Mackie RI, Sghir A, Gaskins HR. Developmental microbial ecology of the neonatal gastrointestinal tract. Am J Clin Nutr. 1999 May;69(5):1035S-1045S. doi: 10.1093/ajcn/69.5.1035s. |
| 9736230 | Background | 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. doi: 10.1080/080352598750013590. |
| 12010580 | Background | 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. |
| 15244234 | Background | 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. |
| 15158604 | Background | Tlaskalova-Hogenova H, Stepankova R, Hudcovic T, Tuckova L, Cukrowska B, Lodinova-Zadnikova R, Kozakova H, Rossmann P, Bartova J, Sokol D, Funda DP, Borovska D, Rehakova Z, Sinkora J, Hofman J, Drastich P, Kokesova A. Commensal bacteria (normal microflora), mucosal immunity and chronic inflammatory and autoimmune diseases. Immunol Lett. 2004 May 15;93(2-3):97-108. doi: 10.1016/j.imlet.2004.02.005. |
| 19030213 | Background | 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. doi: 10.3748/wjg.14.6564. |
| 19172129 | Background | Fanaro S, Marten B, Bagna R, Vigi V, Fabris C, Pena-Quintana L, Arguelles 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. |
| 15198901 | Background | 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. |
| Background | World Health Organization. Nutrient adequacy of exclusive breastfeeding for the term infant during the first six months of life. Geneva, 2002. |
| 26718667 | Derived | Civardi E, Garofoli F, Longo S, Mongini ME, Grenci B, Mazzucchelli I, Angelini M, Castellazzi A, Fasano F, Grinzato A, Fanos V, Budelli A, Stronati M. Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds. Clin Nutr. 2017 Feb;36(1):238-245. doi: 10.1016/j.clnu.2015.11.006. Epub 2015 Nov 27. |
| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
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