Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds

E. Civardi, F. Garofoli, S. Longo, M. E. Mongini, B. Grenci, I. Mazzucchelli, M. Angelini, A. Castellazzi, F. Fasano, A. Grinzato, V. Fanos, A. Budelli, M. Stronati

Research output: Contribution to journalArticle

Abstract

BACKGROUND & AIMS: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula. METHODS: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases. RESULTS: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90% CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in log10CLO, but log10BIF increase was higher at T2 vs. T0 in ENR (treatment x time interaction = 0.71, 95% CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95% CI) values of 8.37 (8.04-8.69) log10-units for ENR vs. 8.08 (7.77-8.39) log10-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups. CONCLUSION: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.
Original languageEnglish
Pages (from-to)238-245
Number of pages8
JournalClinical Nutrition
Volume36
Issue number1
DOIs
Publication statusPublished - Feb 1 2017

Fingerprint

Infant Formula
Randomized Controlled Trials
Microbiota
Newborn Infant
Safety
Growth
Weights and Measures
Aptitude
Bifidobacterium
Clostridium
Gastrointestinal Diseases
Palmitates
Oligosaccharides
Milk
Parents
Head
Bacteria
Gastrointestinal Microbiome
Therapeutics

Keywords

  • Bifidobacterium
  • Clostridium
  • Dietary Carbohydrates/administration & dosage
  • Dietary Fats/administration & dosage
  • Dietary Fiber/administration & dosage
  • Dietary Proteins/administration & dosage
  • Double-Blind Method
  • Food Safety
  • Functional Food/analysis
  • Gastrointestinal Microbiome
  • Gastrointestinal Tract/microbiology
  • Humans
  • Infant
  • Infant Formula/chemistry/microbiology
  • Micronutrients/administration & dosage
  • Treatment Outcome
  • Bifidobacteria
  • Formula
  • Microbiota
  • Neonate

Cite this

Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds. / Civardi, E.; Garofoli, F.; Longo, S.; Mongini, M. E.; Grenci, B.; Mazzucchelli, I.; Angelini, M.; Castellazzi, A.; Fasano, F.; Grinzato, A.; Fanos, V.; Budelli, A.; Stronati, M.

In: Clinical Nutrition, Vol. 36, No. 1, 01.02.2017, p. 238-245.

Research output: Contribution to journalArticle

@article{8e07b8951de84d5a92b2d2b3220131dd,
title = "Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds",
abstract = "BACKGROUND & AIMS: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula. METHODS: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases. RESULTS: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90{\%} CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in log10CLO, but log10BIF increase was higher at T2 vs. T0 in ENR (treatment x time interaction = 0.71, 95{\%} CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95{\%} CI) values of 8.37 (8.04-8.69) log10-units for ENR vs. 8.08 (7.77-8.39) log10-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups. CONCLUSION: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.",
keywords = "Bifidobacterium, Clostridium, Dietary Carbohydrates/administration & dosage, Dietary Fats/administration & dosage, Dietary Fiber/administration & dosage, Dietary Proteins/administration & dosage, Double-Blind Method, Food Safety, Functional Food/analysis, Gastrointestinal Microbiome, Gastrointestinal Tract/microbiology, Humans, Infant, Infant Formula/chemistry/microbiology, Micronutrients/administration & dosage, Treatment Outcome, Bifidobacteria, Formula, Microbiota, Neonate",
author = "E. Civardi and F. Garofoli and S. Longo and Mongini, {M. E.} and B. Grenci and I. Mazzucchelli and M. Angelini and A. Castellazzi and F. Fasano and A. Grinzato and V. Fanos and A. Budelli and M. Stronati",
note = "LR: 20180228; CI: Copyright (c) 2015; JID: 8309603; 0 (Dietary Carbohydrates); 0 (Dietary Fats); 0 (Dietary Fiber); 0 (Dietary Proteins); 0 (Micronutrients); OTO: NOTNLM; 2015/05/29 00:00 [received]; 2015/10/29 00:00 [revised]; 2015/11/09 00:00 [accepted]; 2016/01/01 06:00 [pubmed]; 2018/03/01 06:00 [medline]; 2016/01/01 06:00 [entrez]; ppublish",
year = "2017",
month = "2",
day = "1",
doi = "S0261-5614(15)00326-X [pii]",
language = "English",
volume = "36",
pages = "238--245",
journal = "Clinical Nutrition",
issn = "0261-5614",
publisher = "Churchill Livingstone",
number = "1",

}

TY - JOUR

T1 - Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds

AU - Civardi, E.

AU - Garofoli, F.

AU - Longo, S.

AU - Mongini, M. E.

AU - Grenci, B.

AU - Mazzucchelli, I.

AU - Angelini, M.

AU - Castellazzi, A.

AU - Fasano, F.

AU - Grinzato, A.

AU - Fanos, V.

AU - Budelli, A.

AU - Stronati, M.

N1 - LR: 20180228; CI: Copyright (c) 2015; JID: 8309603; 0 (Dietary Carbohydrates); 0 (Dietary Fats); 0 (Dietary Fiber); 0 (Dietary Proteins); 0 (Micronutrients); OTO: NOTNLM; 2015/05/29 00:00 [received]; 2015/10/29 00:00 [revised]; 2015/11/09 00:00 [accepted]; 2016/01/01 06:00 [pubmed]; 2018/03/01 06:00 [medline]; 2016/01/01 06:00 [entrez]; ppublish

PY - 2017/2/1

Y1 - 2017/2/1

N2 - BACKGROUND & AIMS: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula. METHODS: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases. RESULTS: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90% CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in log10CLO, but log10BIF increase was higher at T2 vs. T0 in ENR (treatment x time interaction = 0.71, 95% CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95% CI) values of 8.37 (8.04-8.69) log10-units for ENR vs. 8.08 (7.77-8.39) log10-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups. CONCLUSION: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.

AB - BACKGROUND & AIMS: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula. METHODS: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases. RESULTS: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90% CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in log10CLO, but log10BIF increase was higher at T2 vs. T0 in ENR (treatment x time interaction = 0.71, 95% CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95% CI) values of 8.37 (8.04-8.69) log10-units for ENR vs. 8.08 (7.77-8.39) log10-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups. CONCLUSION: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.

KW - Bifidobacterium

KW - Clostridium

KW - Dietary Carbohydrates/administration & dosage

KW - Dietary Fats/administration & dosage

KW - Dietary Fiber/administration & dosage

KW - Dietary Proteins/administration & dosage

KW - Double-Blind Method

KW - Food Safety

KW - Functional Food/analysis

KW - Gastrointestinal Microbiome

KW - Gastrointestinal Tract/microbiology

KW - Humans

KW - Infant

KW - Infant Formula/chemistry/microbiology

KW - Micronutrients/administration & dosage

KW - Treatment Outcome

KW - Bifidobacteria

KW - Formula

KW - Microbiota

KW - Neonate

U2 - S0261-5614(15)00326-X [pii]

DO - S0261-5614(15)00326-X [pii]

M3 - Article

VL - 36

SP - 238

EP - 245

JO - Clinical Nutrition

JF - Clinical Nutrition

SN - 0261-5614

IS - 1

ER -