scholarly journals A Partly Fermented Infant Formula with Postbiotics Including 3′-GL, Specific Oligosaccharides, 2′-FL, and Milk Fat Supports Adequate Growth, Is Safe and Well-Tolerated in Healthy Term Infants: A Double-Blind, Randomised, Controlled, Multi-Country Trial

Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3560
Author(s):  
Yvan Vandenplas ◽  
Virginie de Halleux ◽  
Małgorzata Arciszewska ◽  
Piotr Lach ◽  
Valeriy Pokhylko ◽  
...  
Keyword(s):  
Weight Gain ◽  
Infant Formula ◽  
Milk Fat ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Test Group ◽  
Control Group ◽  
Anthropometric Measures ◽  
Double Blind ◽  
Term Infants

This study investigated growth, safety, and tolerance in healthy infants consuming a partly fermented infant formula (IF) with postbiotics, 2′-linked fucosyllactose (2′-FL), a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS), and milk fat. This double-blind, controlled trial randomised 215 fully IF-fed infants ≤ 14 days of age to either: Test Group (IF) containing 26% fermented formula with postbiotics derived from Lactofidus fermentation process (including 3′-Galactosyllactose; 3′-GL), 0.8 g/100 mL scGOS/lcFOS (9:1), 0.1 g/100 mL 2′-FL, and milk fat), or Control group (IF with 0.8 g/100 mL scGOS/lcFOS (9:1)) until 17 weeks of age. Fully breastfed infants were included as a reference. Anthropometric measures, gastrointestinal symptoms, and safety were assessed monthly. Equivalence in weight gain (primary outcome) between the Test and Control groups was confirmed (difference in means −0.08 g/day; 90% CI (−1.47;1.31)) with estimated mean weight gain (SE) of 31.00 (0.59) g/day and 31.08 (0.60) g/day, respectively, (PP population, n = 196). Equivalence in length and head circumference gain between the randomised groups was also confirmed. No statistically significant differences were observed in adverse events or gastrointestinal tolerance between randomised IF groups. A partly fermented IF with postbiotics, specific oligosaccharides, 2′-FL, and milk fat supports adequate infant growth and is safe and well-tolerated in healthy term 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 A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3056
Author(s):  
Eva Karaglani ◽  
Inge Thijs-Verhoeven ◽  
Marjan Gros ◽  
Christina Chairistanidou ◽  
Giorgos Zervas ◽  
...  
Keyword(s):  
Weight Gain ◽  
Infant Formula ◽  
Controlled Trial ◽  
Daily Weight Gain ◽  
Intact Protein ◽  
Control Group ◽  
Intervention Period ◽  
Term Infants ◽  
Randomized Controlled ◽  
Secondary Outcomes

The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55–80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of −3 g/day [mean difference (95% CI) test vs. control: −0.474 (−2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants’ weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term 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 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.

scholarly journals Safety and Tolerance Evaluation of Milk Fat Globule Membrane-Enriched Infant Formulas: A Randomized Controlled Multicenter Non-Inferiority Trial in Healthy Term Infants

2014 ◽  
Vol 8 ◽  
pp. CMPed.S16962 ◽  
Author(s):  
Claude Billeaud ◽  
Giuseppe Puccio ◽  
Elie Saliba ◽  
Bernard Guillois ◽  
Carole Vaysse ◽  
...  
Keyword(s):  
Weight Gain ◽  
Milk Fat ◽  
Bovine Milk ◽  
Control Group ◽  
Infant Formulas ◽  
Term Infants ◽  
Milk Fat Globule Membrane ◽  
Standard Formula ◽  
Milk Fat Globule ◽  
Fat Globule

Objective This multicenter non-inferiority study evaluated the safety of infant formulas enriched with bovine milk fat globule membrane (MFGM) fractions. Methods Healthy, full-term infants ( n = 119) age ≤14 days were randomized to standard infant formula (control), standard formula enriched with a lipid-rich MFGM fraction (MFGM-L), or standard formula enriched with a protein-rich MFGM fraction (MFGM-P). Primary outcome was mean weight gain per day from enrollment to age 4 months (non-inferiority margin: –3.0 g/day). Secondary (length, head circumference, tolerability, morbidity, adverse events) and exploratory (phospholipids, metabolic markers, immune markers) outcomes were also evaluated. Results Weight gain was non-inferior in the MFGM-L and MFGM-P groups compared with the control group. Among secondary and exploratory outcomes, few between-group differences were observed. Formula tolerance rates were high (>94%) in all groups. Adverse event and morbidity rates were similar across groups except for a higher rate of eczema in the MFGM-P group (13.9% vs control [3.5%], MFGM-L [1.4%]). Conclusion Both MFGM-enriched formulas met the primary safety endpoint of non-inferiority in weight gain and were generally well tolerated, although a higher rate of eczema was observed in the MFGM-P group.

scholarly journals Efficacy of a herbal toothpaste on patients with established gingivitis: a randomized controlled trial

2006 ◽  
Vol 20 (2) ◽  
pp. 172-177 ◽  
Author(s):  
Fabiana Ozaki ◽  
Claudio Mendes Pannuti ◽  
Ana Vitória Imbronito ◽  
Wellington Pessotti ◽  
Luciana Saraiva ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Test Group ◽  
Experimental Period ◽  
Positive Control ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Significant Difference ◽  
And Control

The aim of this randomised, double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis. Forty eight volunteers with established gingivitis were randomly assigned to either a test group (herbal dentifrice) or positive control group (dentifrice with triclosan and fluoride). The dentifrices were distributed in plain white tubes by an independent pharmacy, which revealed the contents of each tube only after the experimental period. Plaque and gingivitis assessments were carried out on baseline and after 28 days of product use. All examinations were conducted by the same calibrated investigator. Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days. There was a significant reduction in plaque levels in both the test and control groups. However, there was no significant difference between the groups. A significant reduction in gingivitis was observed in both groups, although there was no significant difference between them. No adverse reactions were reported. The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis.

Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: A Randomized, Double-Blind Controlled Trial

2018 ◽  
Vol 44 (2) ◽  
pp. 122-129
Author(s):  
Arturo Sánchez-Pérez ◽  
Jesús Muñoz-Peñalver ◽  
María José Moya-Villaescusa ◽  
Carmen Sánchez-Matás
Keyword(s):  
Placebo Group ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Double Blind ◽  
Implant Surgery ◽  
Lower Pain ◽  
Dexketoprofen Trometamol ◽  
Group A

The fear of postoperative pain is often mentioned by patients as one of the factors that is most frequently associated with dental implants. To reduce this factor, a single oral dose of 25 mg dexketoprofen trometamol (DKT) or placebo was administered 15 minutes before implant surgery. One hundred patients who required single-implant treatments were randomly assigned to 1 of 2 blinded groups. The patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). A subjective visual analogue scale of 100 mm in length was used to evaluate pain. Inflammation and complications were assessed using a 5-point Likert scale. An analysis of variance, t-tests, and a Mann-Whitney U test were performed. Among the 100 patients, 83 completed the study (there were 8 dropouts in the PLACEBO group and 9 in the DKT group). The patients who received DKT reported a lower pain intensity during the immediate postoperative period. The inflammatory response was weaker in the DKT group than the control group at 48 hours, but bleeding was greater. There were no other complications in either of the groups. In conclusion, the preemptive use of 25 mg soluble DKT administered orally 15 minutes before implant surgery can reduce the severity of immediate postoperative pain.

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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