scholarly journals Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula with a New Lipid Blend and Lactobacillus reuteri (L.reuteri): A Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 959-959
Author(s):  
Yipu Chen ◽  
Rachel Lawenko ◽  
Katherine Buluran ◽  
Ivana Jankovic ◽  
Jowena Lebumfacil ◽  
...  
Keyword(s):  
Infant Formula ◽  
Lactobacillus Reuteri ◽  
Calcium Absorption ◽  
Reference Group ◽  
Controlled Trial ◽  
Saturated Fatty Acids ◽  
Gastrointestinal Symptoms ◽  
Stool Consistency ◽  
Intact Protein ◽  
Gi Symptoms

Abstract Objectives Differences in dietary fat and calcium absorption between breastfed and formula-fed infants may impact gastrointestinal (GI) tolerance and stooling patterns. We hypothesized that infant formula containing L. reuteri and a new lipid blend with low levels of long-chain saturated fatty acids (LCSFAs) (<13% of triacylglycerols [TAG]) in sn-1,3 positions would result in reduced stool calcium-fatty acid (Ca-FA) soaps and improved stool consistency. Methods Healthy term infants 21–28 days (d) of age were randomized in a double-blind manner to receive intact protein cow's milk-based experimental formula (EF, n = 70) with new lipid blend and L. reuteri at 1 × 10,7 CFU/g or control formula (CF, n = 70) without probiotic and containing a lipid blend with high levels of LCSFAs (∼25% of TAG) in sn-1,3 positions until 3 months (m) of age. A breastfed (BF, n = 75) reference group was also included. Co-primary endpoints were stool consistency (via 3-day diary using validated scale from 1 = watery to 5 = hard) and stool total Ca-FA soaps (expressed as mg/g dry stool weight). Overall GI tolerance was assessed using a validated Infant Gastrointestinal Symptoms Questionnaire (IGSQ) (score range: 13 [no GI distress] - 65 [extreme GI distress]). Results Of 215 enrolled infants, 206 completed the study. Infants fed EF had softer stools vs those fed CF by age 1.5 m (stool consistency score: 2.6 ± 0.1 vs 3.0 ± 0.1, P < .0001) and similar to BF (2.7 ± 0.1, P = .089). This positive effect was sustained until age 3 m (EF vs CF, P = .0006; EF vs BF, P = .373; CF vs BF, P = .014), without increased stool frequency in EF vs CF group throughout the study (1.48 vs 1.50 stools/d, P = .884). Infants fed EF (vs CF) had lower stool total Ca-FA soaps at 3 m of age (60.3 ± 10.1 vs 207.9 ± 10.1, P < .0001), largely explained by stool palmitate soaps which was 7 times lower in EF vs CF (20.7 ± 7.0 vs 142.5 ± 6.9 for CF, P < .0001). Mean IGSQ scores remained very low in EF (≤16.2) and CF (≤15.6) groups over the study period. Incidences of parent-reported GI symptoms and physician-confirmed GI adverse events (including diarrhea) were low and similar for EF and CF groups. Conclusions Infant formula containing L. reuteri and enhanced lipid blend with reduced LCSFAs in sn-1,3 positions reduces stool soaps and promotes softer stools closely resembling the stools of breastfed infants. Funding Sources Sponsored by Nestle Nutrition.

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 Term infant formula supplemented with milk-derived oligosaccharides shifts the gut microbiota closer to that of human milk-fed infants and improves intestinal immune defense: A randomized controlled trial

2021 ◽  
Author(s):  
Elvira Estorninos ◽  
Rachel B Lawenko ◽  
Eisel Palestroque ◽  
Norbert Sprenger ◽  
Jalil Benyacoub ◽  
...  
Keyword(s):  
Immune Response ◽  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Human Milk ◽  
Infant Formula ◽  
Controlled Trial ◽  
Immune Defense ◽  
Intact Protein ◽  
Phylogenetic Distance ◽  
Randomized Controlled

Abstract Background Bovine milk-derived oligosaccharides (MOS) containing primarily galacto-oligosaccharides with inherent levels of sialylated oligosaccharides can be added to infant formula to enhance the oligosaccharide profile. Objective To investigate the effects of a MOS-supplemented infant formula on gut microbiota and intestinal immunity. Methods In a double-blind, randomized, controlled trial, healthy-term formula-fed infants aged 21–26 days either received an intact protein cow's milk-based formula (control group, CG, n = 112) or the same formula containing 7.2 g MOS/L (experimental group, EG, n = 114) until age 6 months. Exclusively human milk-fed infants (HFI, n = 70) from an observational study served as reference. Fecal samples collected at baseline, 2.5 and 4 months of age were assessed for microbiota (16S ribosomal ribonucleic acid—based approaches), metabolites and biomarkers of gut health and immune response. Results At age 2.5 and 4 months, redundancy analysis (P = 0.002) and average phylogenetic distance (P &lt; 0.05) showed that the overall microbiota composition in EG was different from CG and closer to that of HFI. Similarly, EG caesarean-born infants were different from CG caesarean- or vaginally-born infants and approaching HFI vaginally-born infants. Relative bifidobacteria abundance was higher in EG vs. CG (P &lt; 0.05) approaching HFI. At age 4 months, counts of Clostridioides difficile and Clostridium perfringens were ∼90% (P &lt; 0.001) and ∼65% (P &lt; 0.01) lower in EG vs. CG, respectively. Mean (95%CI) fecal secretory immunoglobulin A (IgA) in EG was twice that of CG [70 (57,85) vs. 34 (28,42) mg/g, P &lt; 0.001] and closer to HFI. Fecal oral polio vaccine-specific IgA was ∼50% higher in EG vs. CG (P = 0.065). Compared to CG, EG and HFI had lower fecal calcium excretion (by ∼30%) and fecal pH (P &lt; 0.001), and higher lactate concentration (P &lt; 0.001). Conclusions Infant formula with MOS shifts the gut microbiota and metabolic signature closer to that of HFI, has a strong bifidogenic effect, reduces fecal pathogens, and improves intestinal immune response.

The Effect of Lactobacillus reuteri Supplementation in Adults with Chronic Functional Constipation: a Randomized, Double-Blind, Placebo-Controlled Trial*

2014 ◽  
Vol 23 (4) ◽  
pp. 387-391 ◽  
Author(s):  
Veronica Ojetti ◽  
Gianluca Ianiro ◽  
Annalisa Tortora ◽  
Giovanna D‘Angelo ◽  
Teresa Antonella Di Rienzo ◽  
...  
Keyword(s):  
Bowel Movement ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Stool Consistency ◽  
Double Blind ◽  
Movement Frequency ◽  
Bowel Movements ◽  
Bowel Movement Frequency ◽  
The Mean

Background & Aims: There is a growing interest for the use of probiotics for chronic constipation. A recent randomized controlled trial (RCT) showed a positive effect of Lactobacillus reuteri (L. reuteri) on bowel movement frequency in infants with chronic constipation. The aim of the present study was to evaluate the effects of L. reuteri in adult patients with functional constipation.Methods: A double-blind, placebo RCT was conducted in 40 adults (18M/22F, 35±15 years) affected by functional constipation according to the Rome III criteria. Patients were randomly assigned to receive a supplementation of L. reuteri (DSM 17938), or matching placebo for 4 weeks. The increase of bowel movements/week was the primary outcome, while the improvement of stool consistency was the secondary outcome.Results: At week 4, the mean increase in bowel movements/week was 2.6 (SD±1.14, 95% CI:1.6-3.6) in the L. reuteri group and 1.0 (SD±1. 95% CI:0.12-1.88) in the placebo group (p=0.046). At the end of the treatment, the mean bowel movements/week was 5.28±1.93 in the L. reuteri group and 3.89±1.79 in the placebo group. There was a not significant difference in the stool consistency between the two groups.Conclusions: L. reuteri is more effective than the placebo in improving bowel movement frequency in adult patients with functional constipation as previously demonstrated in children, even if it seems to have no effect on stool consistency.

scholarly journals An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial

Nutrients ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 2072 ◽  
Author(s):  
Jean-Charles Picaud ◽  
Barbara Pajek ◽  
Malgorzata Arciszewska ◽  
Izabela Tarczón ◽  
Joaquin Escribano ◽  
...  
Keyword(s):  
Weight Gain ◽  
Adverse Events ◽  
Whey Protein ◽  
Infant Formula ◽  
Reference Group ◽  
Daily Weight Gain ◽  
Intact Protein ◽  
Controlled Clinical Trial ◽  
Serious Adverse Events ◽  
Term Infants

The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow’s milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n = 134) or IPF (n = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/−3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means −1.2 g/d; 90% CI (−2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard intact protein-based formula; it is also safe for use and well-tolerated in healthy term infants.

Effect of probiotics on gastrointestinal symptoms and immune parameters in systemic sclerosis: a randomized placebo-controlled trial

Rheumatology ◽  
2019 ◽  
Vol 58 (11) ◽  
pp. 1985-1990 ◽  
Author(s):  
Thais Fernandes Marighela ◽  
Maria Izabel Arismendi ◽  
Valdecir Marvulle ◽  
Milena Karina Coló Brunialti ◽  
Reinaldo Salomão ◽  
...  
Keyword(s):  
Los Angeles ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Lactobacillus Rhamnosus ◽  
Bifidobacterium Lactis ◽  
Immune Parameters ◽  
Colony Forming Units ◽  
Gi Symptoms ◽  
The University ◽  
To Receive

AbstractObjectivesChanges in the intestinal microbiota have been associated with the pathogenesis of SSc. Probiotics act by modulating the microbiome and the immune response. This study aimed to evaluate the efficacy of probiotics on gastrointestinal (GI) symptoms and immune responses in SSc patients.MethodsPatients with SSc with a moderate–severe total score on the University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 (UCLA GIT 2.0) instrument were randomly assigned to receive a daily dose of probiotics (Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophillus and Bifidobacterium lactis, 109 colony-forming units per capsule) or placebo for 8 weeks. The primary endpoint was improvement in the UCLA GIT 2.0 total score after 8 weeks. Secondary outcomes included changes in Th1, Th2, Th17 and regulatory T cell circulating levels and in the HAQ Disability Index (HAQ-DI) score. Parameters were assessed at baseline and after 4 and 8 weeks of treatment.ResultsA total of 73 patients were randomized to receive probiotics (n = 37) or placebo (n = 36). After 8 weeks, there was no difference in the UCLA GIT 2.0 score between the two groups. At week 8, the probiotic group showed a significant decrease in the proportion of Th17 cells compared with placebo (P = 0.003). There was no difference in the proportion of Th1, Th2 and regulatory T cells or in the HAQ-DI score between the groups.ConclusionProbiotics did not improve GI symptoms in SSc patients. The reduction in Th17 cell levels suggests an immunomodulatory effect of probiotics on SSc.Trial registrationClinicalTrials.gov (http://clinicaltrials.gov), NCT 02302352.

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.

Low FODMAP Diet Is Not Effective in Children with Functional Abdominal Pain: A Randomized Controlled Trial

2020 ◽  
Vol 76 (5) ◽  
pp. 334-344
Author(s):  
Katarzyna Mirosława Boradyn ◽  
Katarzyna Eufemia Przybyłowicz ◽  
Elżbieta Jarocka-Cyrta
Keyword(s):  
Abdominal Pain ◽  
Dietary Intervention ◽  
Rating Scale ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Gastrointestinal Symptoms ◽  
Stool Consistency ◽  
Functional Abdominal Pain ◽  
Abdominal Symptoms ◽  
Fodmap Diet

<b><i>Introduction:</i></b> A diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) has been shown to reduce symptoms among adult patients and children with irritable bowel syndrome. There are no studies investigating the effectiveness of the low FODMAP diet in pediatric patients with functional abdominal pain (FAP). <b><i>Objective:</i></b> The study aimed to evaluate the effectiveness of the low FODMAP diet in reducing gastrointestinal symptoms in children with FAP in comparison to the control diet based on the National Institute for Health and Care Excellence (NICE) guidelines<b>.</b> <b><i>Methods:</i></b> Twenty-seven children with diagnosed FAP were randomized to 2 groups. Each group received an intervention: the low FODMAP diet or the diet based on NICE. All food was prepared and delivered by a catering company. Data regarding gastrointestinal symptoms were recorded by participants during the 2-week baseline assessment and 4-week dietary intervention. The frequencies of abdominal pain and stools were reported as a number of events per day. The severity of abdominal pain was assessed using the Wong-Baker FACES Pain Rating Scale. The assessment of stool consistency was based on the Bristol Stool Form Scale. <b><i>Results:</i></b> The tendency toward the improvement in abdominal symptoms was noted in the low FODMAP group but without statistical significance. No significant differences in stool consistency were observed in this group. The NICE group experienced significant reduction in abdominal pain intensity and frequency (<i>p</i> &#x3c; 0.01) and improvement in stool consistency (93% reporting normal stool, <i>p</i> &#x3c; 0.05). <b><i>Conclusions:</i></b> The results of this pilot study suggest that the low FODMAP diet is not effective in the reduction of symptoms in children with FAP.

scholarly journals A Pooled Analysis of Growth and Tolerance of Infants Exclusively Fed Partially Hydrolyzed Whey or Intact Protein-Based Infant Formulas

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Laura A. Czerkies ◽  
Brian D. Kineman ◽  
Sarah S. Cohen ◽  
Heidi Reichert ◽  
Ryan S. Carvalho
Keyword(s):  
Infant Formula ◽  
Pooled Analysis ◽  
Stool Frequency ◽  
Stool Consistency ◽  
Intact Protein ◽  
Cow’S Milk ◽  
Lower Probability ◽  
Infant Formulas ◽  
Cow's Milk ◽  
Significant Difference

Background. For infants who are partially or exclusively fed infant formula, many options exist with compositional differences between formulas making choices difficult for caregivers and healthcare professionals. The protein in routine infant formulas differs by the source, fraction of cow’s milk protein used, and degree of hydrolysis. All commercially available regulated infant formulas support growth and development, but different stool patterns have been observed based on formula composition. A pooled analysis of seven clinical trials was conducted to examine growth, stool consistency, and stool frequency of infants fed an intact cow’s milk-based formula (CMF) or a partially hydrolyzed whey formula (PHF-W) from a single manufacturer. Methods. Individual subject data from seven infant formula growth studies (3 CMF, 4 PHF-W) were pooled and analyzed. All studies included healthy, full-term, formula-fed infants enrolled at 14 days of age with outcomes assessed over 4 months. Gains in weight and length to 4 months were analyzed using linear regression accounting for clustering within study. Outcomes of caregiver-reported stool consistency and frequency were analyzed using a longitudinal multinomial model. Results. Data from 511 infants were included (197 CMF, 314 PHF-W). There were no differences in weight gain between groups. There was no difference in length gain in girls fed PHF-W while boys fed PHF-W had a significant difference of +0.016 cm/month compared to boys fed CMF. Infants fed PHF-W had a significantly higher probability of soft and lower probability of hard stools as compared to infants fed CMF at each time point (p<0.001). Stool frequency was similar between groups. Conclusions. Infants fed CMF and PHF-W exhibit appropriate growth with comparable gains in weight and length through 4 months. More soft and fewer hard stools are observed in infants fed PHF-W compared to CMF. This difference could help to inform decision-making when choosing an infant formula.

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.

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