scholarly journals Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
J. Maldonado ◽  
M. Gil-Campos ◽  
J. A. Maldonado-Lobón ◽  
M. R. Benavides ◽  
K. Flores-Rojas ◽  
...  
Keyword(s):  
Breast Milk ◽  
Infant Formula ◽  
Controlled Trial ◽  
Study Groups ◽  
Control Group ◽  
Milk Formula ◽  
Powdered Infant Formula ◽  
Double Blind ◽  
Bifidobacterium Breve ◽  
Link Type

Abstract Background The microorganism present in breast milk, added to other factors, determine the colonization of infants. The objective of the present study is to evaluate the safety, tolerance and effects of the consumption of a milk formula during the first year of life that is supplemented with L. fermentum CECT5716 or Bifidobacterium breve CECT7263, two strains originally isolated from breast milk. Methods A randomized, double blind, controlled, parallel group study including healthy, formula-fed infants was conducted. Two hundred and thirty-six 1-month-old infants were selected and randomly divided into three study groups according to a randomization list. Infants in the control group received a standard powdered infant formula until 12 months of age. Infants in the probiotic groups received the same infant formula but supplemented with L. fermentum CECT5716 Lc40 or B. breve CECT7263. Main outcome was weigh-gain of infants as safety marker. Results One hundred and eighty-nine infants completed the eleven months of intervention (61 in control group, 65 in Lf group and 63 in Bb group). The growth of infants in the three groups was consistent with standards. No significant differences were observed in the main outcome, weight-gain (Control group: 5.77 Kg ± 0.95, Lf group: 5.77 Kg ± 1.31, Bb group: 5.58 Kg ± 1.10; p = 0.527). The three milk formulae were well tolerated, and no adverse effects were related to the consumption of any of the formula. Infants receiving B. breve CECT7263 had a 1.7 times lower risk of crying than the control group (OR = 0.569, CI 95% 0.568–0.571; p = 0.001). On the other hand, the incidence of diarrhoea in infants receiving the formula supplemented with L. fermentum CECT5716 was a 44% lower than in infants receiving the control formula (p = 0.014). The consumption of this Lactobacillus strain also reduced the duration of diarrhoea by 2.5 days versus control group (p = 0.044). Conclusions The addition of L. fermentum CECT5716 Lc40 or B. breve CECT7263, two probiotic strains naturally found in breast milk, to infant formulae is safe and induces beneficial effects on the health of infants. Trial registration The trial was retrospectively registered in the US Library of Medicine (www.clinicaltrial.gov) with the number NCT03204630. Registered 11 August 2016.

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 Reducing Iron Content in Infant Formula from 8 to 2 mg/L Does Not Increase the Risk of Iron Deficiency at 4 or 6 Months of Age: A Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 3
Author(s):  
Maria Björmsjö ◽  
Olle Hernell ◽  
Bo Lönnerdal ◽  
Staffan K. Berglund
Keyword(s):  
Breast Milk ◽  
Iron Deficiency ◽  
Infant Formula ◽  
Iron Content ◽  
Iron Status ◽  
Controlled Trial ◽  
Bovine Lactoferrin ◽  
High Concentration ◽  
Double Blind ◽  
Term Infants

Many infant formulas are fortified with iron at 8–14 mg/L whereas breast milk contains about 0.3 mg/L. Another major difference between breast milk and infant formula is its high concentration of lactoferrin, a bioactive iron-binding protein. The aim of the present study was to investigate how reducing the iron content and adding bovine lactoferrin to infant formula affects iron status, health and development. Swedish healthy full-term formula-fed infants (n = 180) were randomized in a double-blind controlled trial. From 6 weeks to 6 months of age, 72 infants received low-iron formula (2 mg/L) fortified with bovine lactoferrin (1.0 g/L) (Lf+), 72 received low-iron formula un-fortified with lactoferrin (Lf−) and 36 received standard formula with 8 mg of iron/L and no lactoferrin fortification as controls (CF). Iron status and prevalence of iron deficiency (ID) were assessed at 4 and 6 months. All iron status indicators were unaffected by lactoferrin. At 4 and 6 months, the geometric means of ferritin for the combined low-iron groups compared to the CF-group were 67.7 vs. 88.7 and 39.5 vs. 50.9 µg/L, respectively (p = 0.054 and p = 0.056). No significant differences were found for other iron status indicators. In the low-iron group only one infant (0.7%) at 4 months and none at 6 months developed ID. Conclusion: Iron fortification of 2 mg/L is an adequate level during the first half of infancy for healthy term infants in a well-nourished population. Adding lactoferrin does not affect iron status.

Synbiotic supplementation is not effective on breast milk selenium concentrations and growth of exclusively breast fed infants: a pilot study

2019 ◽  
Vol 89 (1-2) ◽  
pp. 73-79 ◽  
Author(s):  
Leila Nikniaz ◽  
Reza Mahavi ◽  
Alireza Ostadrahimi ◽  
Zeinab Nikniaz ◽  
Sharare Taghipour
Keyword(s):  
Pilot Study ◽  
Breast Milk ◽  
Graphite Furnace ◽  
Controlled Trial ◽  
Study Groups ◽  
Z Score ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract. In this randomized, double-blind, placebo-controlled trial, 57 lactating mothers were randomly allocated into two groups to receive a daily supplement of synbiotic (n = 30) which contained different probiotic strains (2.0 × 108 CFU) and fructooligosaccharide (394 mg) or a placebo (n = 27) for 30 days. Dietary intake was collected from lactating women by 24-hour recall method. Breast milk selenium contents were determined by atomic absorption spectrometry with graphite furnace. Weight for age Z-score (WAZ) and Height for age Z-score (HAZ) were evaluated for infants. Data analyses were assessed using nutritionist IV, Epi Info and SPSS software and presented as mean ± sd or SEM. The total mean breast milk selenium levels were 50.1 ± 16.1 mcg L−1. At the baseline, the mean breast milk selenium concentrations in the synbiotic and placebo groups were 51.7 ± 20.2 and 48.5 ± 12.1 mcg L−1. The mean breast milk selenium levels increased and decreased in the symbiotic and placebo groups respectively, which were not significant (p > 0.05). Also, comparison of the changes in breast milk selenium concentration showed no significant difference between the two study groups after the intervention. At the baseline, the mean WAZ and HAZ of infants whose mothers’ milk selenium was more than 60 mcg/l was significantly (P < 0.05) higher than for others. In this pilot study, no significant effect was observed by synbiotic supplementation, however, for concise conclusion, more human studies with higher doses of supplements and longer duration of supplementation are needed to determine the effects of synbiotic supplementation on breast milk selenium contents and infants’ growth.

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 Effects of Dexamethasone on Post-dural Puncture Headache in Patients Undergoing Orthopedic Surgery

2020 ◽  
Vol 13 (1) ◽  
pp. 42-46
Author(s):  
Hadis Barkhori ◽  
Farhad Arefi ◽  
Kiavash Hushmandi ◽  
Salman Daneshi ◽  
Jafar Salehi ◽  
...  
Keyword(s):  
Orthopedic Surgery ◽  
Dural Puncture ◽  
Controlled Trial ◽  
Study Groups ◽  
Control Group ◽  
Double Blind ◽  
Post Dural Puncture Headache ◽  
Double Blind Placebo ◽  
Dexamethasone Group ◽  
Post Operative Period

Background: The effect of Dexamethasone on Post-Dural Puncture Headache (PDPH) after spinal anesthesia has not been well elucidated. The aim of the current study was to evaluate the effect of prophylactic intravenous dexamethasone on the incidence and severity of PDPH in patients undergoing orthopedic surgery. Methods: This randomized, double-blind, placebo-controlled trial was carried out in patients undergoing orthopedic surgery. The subjects were randomly divided into a placebo (n=140) and a dexamethasone (n=140) group. During the surgery, the control group participants were injected 2cc of distilled water, and the dexamethasone group participants were injected 2cc (8mg) of dexamethasone as an infusion in the veins. The incidences of PDPH on the first, third and seventh postoperative days were studied. Data were analyzed using SPSS version 22. Results: A total of 280 patients with a mean age of 32.7 ± 11.0 years were studied. The incidence of PDPH on the first day of post-operative period was lower in the dexamethasone group than the control group (21 vs. 34, P<0.05). This difference was disappeared on days 3 and 7. Nausea or vomiting occurred less in the dexamethasone group (9 vs. 26, P<0.05). However, no statistically significant association was found between study groups and the incidence of back pain (P>0.05). Conclusion: Although the frequency of PDPH was less in patients receiving dexamethasone, the incidence increased days after the operation and reached the level of the placebo group. We do not recommend prophylactic intravenous dexamethasone for the prevention of PDPH.

scholarly journals Diphenhydramine Definitely Suppresses Fentanyl-Induced Cough During General Anesthesia Induction: A Double-Blind, Randomized, and Placebo-Controlled Study

2019 ◽  
Author(s):  
Pejman Pourfakhr ◽  
Seyed Hashem Ziaei ◽  
Farhad Etezadi ◽  
Mohamadreza Sharifinia ◽  
Mohammad Reza Khajavi
Keyword(s):  
Recovery Room ◽  
Controlled Trial ◽  
Study Groups ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Control Group ◽  
Anesthesia Induction ◽  
Analgesic Requirement ◽  
Double Blind ◽  
Number Of Patients

Fentanyl-induced cough (FIC) is a known complication, and many studies have been conducted to prevent it. The aim of this study was to evaluate the effectiveness of Diphenhydramine as an antihistamine in suppressing of FIC during induction of anesthesia. In a prospective, double-blind, randomized controlled trial, a total of 100 patients, ASA Class I and II, scheduled for elective laparoscopy surgery were randomly assigned into two equally sized groups (n=50). Diphenhydramine diluted with distilled water as 10 mg/ml. Then, patients in Group D, received diphenhydramine 30 mg (3 ml) through peripheral IV line within 1 min and Group C received the same volume normal saline 0.9% as placebo. Two min later, fentanyl 2 µg/kg was administered through the peripheral IV line within 5 sec in all patients. The occurrence and intensity of cough within 2 min after the fentanyl injection were observed and recorded by a resident who was blinded to the study groups. The frequency of PONV, analgesic requirement in the recovery room and as a secondary outcome were recorded. The incidences of FIC were 47% in the control group, and there is no cough in the diphenhydramine group (P=0.02). The frequency of PONV was also reduced in diphenhydramine group (16% vs. 40%) and less number of patients in diphenhydramine group was needed to analgesia in the recovery room (60% vs. 82%). Our study determines that diphenhydramine (30 mg, IV) bolus injection 2 min before fentanyl injection can prevent FIC and PONV and also reduce analgesic requirement inthe recovery room. © 2019 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2019;57(5):316-319.

scholarly journals An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial

2011 ◽  
Vol 107 (11) ◽  
pp. 1616-1622 ◽  
Author(s):  
Jean-Christophe Rozé ◽  
Sébastien Barbarot ◽  
Marie-José Butel ◽  
Nathalie Kapel ◽  
Anne-Judith Waligora-Dupriet ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Infant Formula ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Secretory Iga ◽  
Control Group ◽  
Double Blind ◽  
Randomised Controlled ◽  
Similar Growth ◽  
Experimental Group

The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P = 0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P < 0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P < 0·014) and negatively correlated to the level of colonisation by bifidobacteria (P < 0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.

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 Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

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