scholarly journals Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1481 ◽  
Author(s):  
Mireille Castanet ◽  
Christos Costalos ◽  
Nadja Haiden ◽  
Jean-Michel Hascoet ◽  
Bernard Berger ◽  
...  
Keyword(s):  
Reference Group ◽  
Controlled Trial ◽  
Bovine Milk ◽  
Double Blind ◽  
Term Infants ◽  
Early Effect ◽  
Breastfed Infants ◽  
Infant Formulae ◽  
Formula Group ◽  
Gut Maturation

Background: Post-natal gut maturation in infants interrelates maturation of the morphology, digestive, and immunological functions and gut microbiota development. Here, we explored both microbiota development and markers of gut barrier and maturation in healthy term infants during their early life to assess the interconnection of gut functions during different infant formulae regimes. Methods: A total of 203 infants were enrolled in this randomized double-blind controlled trial including a breastfed reference group. Infants were fed starter formulae for the first four weeks of life, supplemented with different combination of nutrients (lactoferrin, probiotics (Bifidobacterium animal subsp. Lactis) and prebiotics (Bovine Milk-derived Oligosaccharides—BMOS)) and subsequently fed the control formula up to eight weeks of life. Stool microbiota profiles and biomarkers of early gut maturation, calprotectin (primary outcome), elastase, α-1 antitrypsin (AAT) and neopterin were measured in feces at one, two, four, and eight weeks. Results: Infants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups. Elastase and AAT levels were closer to levels observed in breastfed infants. No differences were observed for neopterin. Global differences between the bacterial communities of all groups were assessed by constrained multivariate analysis with hypothesis testing. The canonical correspondence analysis (CCA) at genus level showed overlap between microbiota profiles at one and four weeks of age in the BMOS supplemented formula group with the breastfed reference, dominated by bifidobacteria. Microbiota profiles of all groups at four weeks were significantly associated with the calprotectin levels at 4 (CCA, p = 0.018) and eight weeks of age (CCA, p = 0.026). Conclusion: A meaningful correlation was observed between changes in microbiota composition and gut maturation marker calprotectin. The supplementation with BMOS seems to favor gut maturation closer to that of breastfed infants.

scholarly journals Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1530 ◽  
Author(s):  
Alfonso Rodriguez-Herrera ◽  
Kelly Mulder ◽  
Hetty Bouritius ◽  
Rocio Rubio ◽  
Antonio Muñoz ◽  
...  
Keyword(s):  
Infant Formula ◽  
Reference Group ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Control Infant ◽  
Breastfed Infants ◽  
Experimental Versus

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

scholarly journals Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial

2009 ◽  
Vol 101 (11) ◽  
pp. 1706-1713 ◽  
Author(s):  
Robert A. Gibson ◽  
Denis Barclay ◽  
Helen Marshall ◽  
Julie Moulin ◽  
Jean-Claude Maire ◽  
...  
Keyword(s):  
Weight Gain ◽  
Infant Formula ◽  
Head Circumference ◽  
Controlled Trial ◽  
Double Blind ◽  
Term Infants ◽  
Bifidobacterium Lactis ◽  
Significant Difference ◽  
Formula Group ◽  
Long Chain

Probiotics and long-chain PUFA (LC-PUFA) may be beneficial supplements for infants who are not breast-fed. The aim of the present study is to evaluate the safety of an infant formula containing the LC-PUFA DHA and arachidonic acid (AA) and the probiotic Bifidobacterium lactis by comparing the growth rate of infants fed the supplemented and unsupplemented formulas. One hundred and forty-two healthy, term infants were enrolled in a single-centre, randomised, double-blind, controlled, parallel-group trial, and allocated to receive either standard or probiotic and LC-PUFA-containing experimental formulas. The infants were fed with their assigned formulas for 7 months. The primary outcome (weight gain) and the secondary outcomes (length, head circumference and formula tolerance) were measured throughout the study. LC-PUFA status was assessed at 4 months of age and immune response to childhood vaccines was measured at 7 months of age. There was no significant difference in growth between the two groups. The 90 % CI for the difference in mean weight gain was − 0·08, 3·1 g in the intention-to-treat population and 0·1–3·8 g in the per protocol population, which lay within the predefined boundaries of equivalence, − 3·9–3·9. There were no significant differences in mean length and head circumference. DHA and AA concentrations were higher in infants in the experimental formula group compared with the control formula group. No influence of the supplements on the response to vaccines was observed. Growth characteristics of term infants fed the starter formula containing a probiotic and LC-PUFA were similar to standard formula-fed infants.

scholarly journals Effect of milk fat-based infant formulae on stool fatty acid soaps and calcium excretion in healthy term infants: two double-blind randomised cross-over trials

BMC Nutrition ◽  
2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Yannis Manios ◽  
Eva Karaglani ◽  
Inge Thijs-Verhoeven ◽  
Elpis Vlachopapadopoulou ◽  
Anastasia Papazoglou ◽  
...  
Keyword(s):  
Fatty Acid ◽  
Milk Fat ◽  
Bovine Milk ◽  
Dry Weight ◽  
Stool Consistency ◽  
Calcium Excretion ◽  
Double Blind ◽  
Term Infants ◽  
Infant Formulae ◽  
Significant Difference

Abstract Background Palmitic acid (PA) is predominantly esterified at the SN-2 position of triacylglycerols in human milk. PA at the SN-2 position is more efficiently absorbed and results in reduced formation of PA soaps, as well as reduced fatty acid (FA) and calcium malabsorption. Bovine milk fat (MF), a natural source of SN-2-palmitate, was used in the fat blend of infant formulae (IF) in the current study to investigate its effect on stool fatty acid soaps, calcium excretion and stool characteristics. Methods Two double-blind, randomised cross-over trials (CS1, CS2) were conducted in parallel with healthy term, formula-fed infants aged 9–14 weeks. After a two-week run-in period, infants in CS1 (n = 17) were randomly allocated to receive either a 50% MF-based formula (50MF) or a 100% vegetable fat (VF) formula; in CS2 (n = 18), infants received either a 20% MF-based formula (20MF) or the VF formula, in a 2 × 2-week cross-over design. At the end of each two-week intervention period, stool samples were collected for FA, FA soaps and calcium excretion analysis and stool consistency was assessed according to the Amsterdam Infant Stool Scale (AISS). Results MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight, p < 0.0001; CS2: 216.24 ± 25.16 vs. 233.94 ± 35.12 mg/g dry weight, p = 0.0023), total FA soaps and calcium excretion (CS1: 46.40 ± 5.27 vs. 49.88 ± 4.77 mg/g dry weight, p = 0.0041; CS2: 46.20 ± 4.26 vs. 50.47 ± 6.71 mg/g dry weight, p = 0.0067) were observed. Furthermore, the 50MF group showed a favourable lower mean stool consistency score compared to the VF group (1.64 ± 0.49 vs. 2.03 ± 0.19, p = 0.0008). Conclusions While the use of bovine MF in IF did not affect PA concentrations in stool, lower excretion of palmitate soaps, total FA soaps and calcium was seen in healthy term infants. 50MF formula also showed improved stool consistency. The use of MF in IF could be an interesting approach to improve gut comfort and stool characteristics in infants, warranting further research. Trial registration Netherlands Trial Registry Identifier: NTR6702. Date registered: December 01, 2017.

Infant formula with galacto-oligosaccharides (OM55N) stimulates the growth of indigenous bifidobacteria in healthy term infants

2016 ◽  
Vol 7 (4) ◽  
pp. 453-461 ◽  
Author(s):  
T. Matsuki ◽  
S. Tajima ◽  
T. Hara ◽  
K. Yahagi ◽  
E. Ogawa ◽  
...  
Keyword(s):  
Infant Formula ◽  
Controlled Trial ◽  
Shannon Index ◽  
Present Species ◽  
Double Blind ◽  
Term Infants ◽  
Breastfed Infants ◽  
Trial Onset ◽  
Α Diversity ◽  
Faecal Samples

The objective of the study was to investigate whether an infant formula supplemented with galacto-oligosaccharides (GOS; OM55N) was able to stimulate the growth of indigenous bifidobacteria and to establish microbiota similar to that of breastfed infants. A randomised, double-blind, placebo-controlled trial was performed using 35 healthy term infants (31-54 days of age; 42±6 days) to determine whether infant formula with 0.3 g/dl GOS (OM55N) stimulated the growth of bifidobacteria in the infants’ guts. At the trial onset and 2 weeks after, the infants’ faecal samples were examined for microbiota composition (bacterial abundance and α-diversity) and faecal characteristics. Among the 35 infants, 5 were withdrawn and 8 were excluded from the final evaluation before breaking the blinding since the indigenous bifidobacteria were not detected at the trial onset. After 2 weeks, the abundance of Bifidobacteriaceae was significantly increased in the GOS feeding group compared to the control (+11.6±24.1% vs -3.9±13.0%; P=0.043). The Shannon index, which accounts for both abundance and evenness of the present species, was significantly decreased with GOS supplementation (-0.1±0.4 vs +0.4±0.4; P=0.014). Faecal characteristics such as pH and organic acids were similar in both groups, with no statistical differences. No adverse side effects related to the formula consumption were reported. Although the concentration of GOS was relatively low, the infant formula with GOS increased the abundance of bifidobacteria and resulted in a reduced α-diversity of the microbiota.

scholarly journals Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1276
Author(s):  
Franka Neumer ◽  
Orenci Urraca ◽  
Joaquin Alonso ◽  
Jesús Palencia ◽  
Vicente Varea ◽  
...  
Keyword(s):  
Infant Formula ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
First Year ◽  
Double Blind Study ◽  
Double Blind ◽  
Term Infants ◽  
Intention To Treat ◽  
Prebiotic Oligosaccharides ◽  
First Year Of Life

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.

Growth and Tolerance of Healthy Term Infants Receiving Hydrolyzed Infant Formulas Supplemented WithLactobacillus rhamnosusGG: Randomized, Double-Blind, Controlled Trial

2009 ◽  
Vol 48 (7) ◽  
pp. 734-744 ◽  
Author(s):  
Deolinda M. Scalabrin ◽  
William H. Johnston ◽  
Dennis R. Hoffman ◽  
Virginia L. P'Pool ◽  
Cheryl L. Harris ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Infant Formulas ◽  
Double Blind ◽  
Term Infants

scholarly journals Normal Growth of Healthy Infants Born from HIV+ Mothers Fed a Reduced Protein Infant Formula Containing the Prebiotics Galacto-Oligosaccharides and Fructo-Oligosaccharides: A Randomized Controlled Trial

2015 ◽  
Vol 9 ◽  
pp. CMPed.S17841
Author(s):  
Hugo Da Costa Ribeiro Júnior ◽  
Tereza Cristina Medrado Ribeiro ◽  
Angela Peixoto De Mattos ◽  
Mariana Pontes ◽  
Roseli Oselka Saccardo Sarni ◽  
...  
Keyword(s):  
Weight Gain ◽  
Infant Formula ◽  
Controlled Trial ◽  
Normal Growth ◽  
Daily Weight Gain ◽  
Term Infants ◽  
Intention To Treat ◽  
Formula Group ◽  
The Difference ◽  
Breast Fed

Objective The aim of the current study was to evaluate the safety of a new reduced protein (2.1 g/100 kcal) infant formula containing 4 g/L of 90% galacto-oligosaccharides (GOS) and 10% fructo-oligosaccharides (FOS). Methods Healthy term infants from Brazil were enrolled. Those born to human immunodeficiency virus (HIV)-positive mothers were randomized to a test ( n = 65) or control ( n = 63) formula group. Infants born to HIV-negative mothers were either exclusively breast-fed ( n = 79) or received a mixed diet (breast milk and test formula, n = 65). Between 2 weeks and 4 months of age, infants were exclusively fed according to their assigned group. Anthropometric measurements were taken at baseline, 1, 2, 3, 4, 6, 8, 10, and 12 months. Digestive tolerance was evaluated during the first 4 months. The primary outcome was mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups. Results Data from all infants ( N = 272) were used in the intention-to-treat (ITT) analysis and data from 230 infants were used in the per-protocol (PP) analysis. The difference in mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups was 1.257 g/day (onesided 95% confidence interval [CI]: -0.705 to inf, P < 0.001) in the PP analysis, showing that the lower bound of the 95% CI was above the -3.0 g/day non-inferiority margin. Results were similar in the ITT analysis. Symptoms of digestive tolerance and frequency of adverse events were similar in the two groups. Conclusions The formula containing 2.1 g/100 kcal protein and GOS and FOS was safe and tolerated well.

scholarly journals Milk fat-based formula reduced palmitic acid soaps and excretion of calcium in healthy term infants: two double-blind, randomized, cross-over trials

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Yannis Manios ◽  
Eva Karaglani ◽  
Inge Thijs-Verhoeven ◽  
Elpis Vlachopapadopoulou ◽  
Anastasia Papazoglou ◽  
...  
Keyword(s):  
Palmitic Acid ◽  
Infant Formula ◽  
Milk Fat ◽  
Bovine Milk ◽  
Calcium Excretion ◽  
Double Blind ◽  
Term Infants ◽  
Stool Samples ◽  
To Receive ◽  
Vegetable Fat

AbstractIntroduction:Infant formula (IF) with vegetable fat blends typically have more than 80% of palmitic acid (PA) esterified at the sn-1 and sn-3 positions of triglycerides. Additional use of bovine milk fat (MF), a natural source of sn-2 palmitate, may enable increasing the sn-2 palmitate levels, potentially leading to improved absorption of fatty acids and calcium, and reduced formation of PA soaps associated with constipation in infants. The current study investigated the effect of IF with and without MF on the concentration of PA, PA soaps, calcium excretion and gastrointestinal tolerance using Amsterdam Infant Stool Scale (AISS) in healthy term infants.Materials and Methods:Two double-blind randomized placebo-controlled cross-over trials were conducted in parallel to compare a MF-based test formula with high sn-2 palmitate levels (39%) with a reference formula with only vegetable fat (10.1% sn-2 palmitate, cross-over study 1; CS1) and a MF-based test formula with medium sn-2 palmitate levels (19.7%) with the reference formula with only vegetable fat (cross-over study 2; CS2). CS1 included 17 and CS2 18 full-term, healthy, exclusively formula-fed infants screened between the 9th-14th week of age. After two weeks of wash-out period, in both CS1 and CS2, infants were randomized to receive either the MF-based test formula or reference. At the end of two weeks, the groups were crossed-over to receive the other formula for subsequent two weeks. Stool samples were collected after each two-week intervention period and bi-weekly diaries and questionnaires were completed by the parents/caretakers.Results:The PA concentrations in stools (mg/g dry weight) did not differ between the MF-based test and reference formula in either CS1 (p = 0.1324) or CS2 (p = 0.1198). A reduction was observed in the concentration of PA soaps in both medium and high sn-2 palmitate formula, with a more pronounced effect for the high sn-2 palmitate formula (medium; p = 0.0023 and high; p < 0.0001). In addition, calcium excretion in stools was significantly lower in the MF-based formula groups as compared to the reference in both studies (medium; p = 0.0067 and high; p = 0.0041). In CS2, stool consistency did not differ between groups whilst in CS1, a favorable effect of high sn-2 palmitate formula compared to the reference formula (p = 0.0008) was noted.Conclusion:Bovine milk fat in infant formula reduced the excretion of PA soaps and calcium in stool samples of healthy term infants. High sn-2 palmitate formula showed a more pronounced effect and improved stool consistency according to the AISS.

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