scholarly journals Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial

2016 ◽  
Vol 81 (4) ◽  
pp. 622-631 ◽  
Author(s):  
Michael Radke ◽  
Jean-Charles Picaud ◽  
Andrea Loui ◽  
Gilles Cambonie ◽  
Dirk Faas ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Infant Formula ◽  
Odds Ratio ◽  
Bovine Milk ◽  
Test Group ◽  
Normal Infant ◽  
Gut Health ◽  
Double Blind ◽  
Term Infants ◽  
Significant Difference

Abstract Background: Prebiotics and probiotics exert beneficial effects by modulating gut microbiota and immune system. This study evaluates efficacy and safety of an infant formula containing bovine milk-derived oligosaccharides and Bifidobacterium animalis ssp lactis (B. lactis) (CNCM I-3446) on incidence of diarrhea and febrile infections during the first year of life (primary outcome). Methods: Full-term infants receiving Test or Control (without bovine milk-derived oligosaccharide and B. lactis) formulae were enrolled in a multicenter, randomized, controlled, and double-blind trial with a reference breastfeeding group. . Results: 413 infants were assigned between Test (n = 206) and Control (n = 207) formula. There was no significant difference for diarrhea and febrile infections incidence between groups at 6 (odds ratio (95% confidence interval) = 0.56 (0.26–1.15), P = 0.096) and 12 mo (odds ratio = 0.66 (0.38–1.14), P = 0.119). Test formula was well tolerated, anthropometrics parameters were not significantly different between groups and aligned with WHO growth standards up to 12 mo. Data from test group showed that gut microbiota pattern, fecal IgA and stool pH were brought to be closer to those of breastfed infants. Conclusion: An infant formula enriched with bovine milk-derived oligosaccharide and B. lactis supports normal infant growth, is well tolerated and improves intestinal health markers. No differences in diarrhea and febrile infection incidence were found in the population studied.

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.

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 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.

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 Gut Microbiota May Not Be Fully Restored in Recovered COVID-19 Patients After 3-Month Recovery

2021 ◽  
Vol 8 ◽  
Author(s):  
Yu Tian ◽  
Kai-yi Sun ◽  
Tian-qing Meng ◽  
Zhen Ye ◽  
Shi-meng Guo ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Bacterial Species ◽  
Short Chain Fatty Acids ◽  
Sequencing Analysis ◽  
Gut Health ◽  
Opportunistic Pathogens ◽  
Recovery Stage ◽  
Β Diversity ◽  
Significant Difference ◽  
Male Patients

Coronavirus disease 2019 (COVID-19) has infected over 124 million people worldwide. In addition to the development of therapeutics and vaccines, the evaluation of the sequelae in recovered patients is also important. Recent studies have indicated that COVID-19 has the ability to infect intestinal tissues and to trigger alterations of the gut microbiota. However, whether these changes in gut microbiota persist into the recovery stage remains largely unknown. Here, we recruited seven healthy Chinese men and seven recovered COVID-19 male patients with an average of 3-months after discharge and analyzed their fecal samples by 16S rRNA sequencing analysis to identify the differences in gut microbiota. Our results suggested that the gut microbiota differed in male recovered patients compared with healthy controls, in which a significant difference in Chao index, Simpson index, and β-diversity was observed. And the relative abundance of several bacterial species differed clearly between two groups, characterized by enrichment of opportunistic pathogens and insufficiency of some anti-inflammatory bacteria in producing short chain fatty acids. The above findings provide preliminary clues supporting that the imbalanced gut microbiota may not be fully restored in recovered patients, highlighting the importance of continuous monitoring of gut health in people who have recovered from COVID-19.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

scholarly journals THE CLINICAL EFFECT OF A NEW INFANT FORMULA IN TERM INFANTS WITH CONSTIPATION: A DOUBLE-BLIND, RANDOMIZED TRIAL.

2005 ◽  
Vol 41 (Supplement 1) ◽  
pp. S78
Author(s):  
M EJ Bongers ◽  
F de Lorijn ◽  
JB Reitsma ◽  
MI Groeneweg ◽  
JAJM Taminiau ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Infant Formula ◽  
Clinical Effect ◽  
Double Blind ◽  
Term Infants

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.

scholarly journals Randomised controlled general practice trial of sertraline, exposure therapy and combined treatment in generalised social phobia

2001 ◽  
Vol 179 (1) ◽  
pp. 23-30 ◽  
Author(s):  
S. Blomhoff ◽  
T. T. Haug ◽  
K. Hellström ◽  
I. Holme ◽  
M. Humble ◽  
...  
Keyword(s):  
General Practice ◽  
Social Phobia ◽  
Odds Ratio ◽  
Exposure Therapy ◽  
Controlled Trial ◽  
Combined Treatment ◽  
Practice Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Double Blind Design

BackgroundNo controlled trial of treatment of generalised social phobia has been conducted in general practice.AimsTo examine the efficacy of sertraline or exposure therapy, administered alone or in combination in this setting.MethodStudy was of a randomised, double-blind design. Patients (n=387) received sertraline 50–150 mg or placebo for 24 weeks. Patients were additionally randomised to exposure therapy or general medical care.ResultsSertraline-treated patients were significantly more improved than non-sertraline-treated patients (χ2=12.53, P<0.001; odds ratio=0.534; 95% CI 0.347–0.835). No significant difference was observed between exposure— and non-exposure-treated patients (χ2=2.18, P=0.140; odds ratio=0.732; 95% CI 0.475–1.134). In the pairwise comparisons, combined sertraline and exposure (χ2=12.32; P<0.001) and sertraline (χ2=10.13; P=0.002) were significantly superior to placebo.ConclusionsSertraline is an effective treatment for generalised social phobia. Combined treatment with sertraline and exposure therapy, conducted by the general practitioner, may enhance the treatment efficacy in primary care.

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