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Effects of Banafine® , a fermented green banana-derived acidic glycoconjugate, on influenza vaccine antibody titer in elderly patients receiving gastrostomy tube feeding.
Horie, K, Hossain, MS, Kim, Y, Akiko, I, Kon, R, Yamatsu, A, Kishima, M, Nishikimi, T, Kim, M
Journal of food science. 2021;(4):1410-1417
Abstract
Immunosenescence can negatively affect cytokine production in elderly and may impair poor antibody responses to influenza vaccination and infection. Herein, the effects of Banafine® administration on influenza vaccine antibody titer in elderly patients (average age ∼80 years) receiving gastrostomy tube feeding were examined. In the double-blind, single-center, randomized clinical studies, 30 elderly bedridden patients were administered Banafine® or placebo for 8 weeks. At week 4, all patients received influenza vaccination against H1N1, H3N2, B/Yamagata, or B/Victoria. Blood biochemical indices and serum antibody titers were assessed. Banafine® administration significantly increased hemagglutination inhibition titers in response to vaccination against H1N1, H3N2, and B/Yamagata in the elderly patients (P < 0.05). Moreover, the seroconversion rate against H1N1 (47.1%) and H3N2 (29.4%) and seroprotection rate against H1N1 (71.4%) and both B strains (31.3% and 12.5%, respectively) were increased for the Banafine® group. These results suggest that Banafine® administration can increase antibody responses to influenza vaccination in bedridden hospitalized patients, and potentially modulate immune function in the elderly. PRACTICAL APPLICATION Literature review suggested that most of the synbiotics are based on innate immunity, strain specific (probiotics), and are not consistently observed. Herein, in clinical studies we demonstrate that administration of Banafine® , a plant-based glycoconjugate, can increase antibody levels in bedridden hospitalized elderly patients following influenza vaccination.
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Efficacy and Safety of Enteral Recombinant Human Insulin for Reduction of Time-to-Full Enteral Feeding in Preterm Infants: A Randomized, Double-blind, Placebo-Controlled Trial.
Shehadeh, N, Simmonds, A, Zangen, S, Riskin, A, Shamir, R
The Israel Medical Association journal : IMAJ. 2021;(9):563-568
Abstract
BACKGROUND Infants born very prematurely have functionally and structurally immature gastrointestinal tracts. OBJECTIVES To assess the safety and tolerability of administration of enteral recombinant human (rh) insulin on formula fed preterm infants and to assess whether enteral administration of rh-insulin enhances gastrointestinal tract maturation by reducing the time to reach full enteral feeding. METHODS A phase 2, multicenter, double-blind, placebo-controlled, randomized study was conducted. Premature infants (26-33 weeks gestation) were randomized 1:1 to receive insulin 400 μU/ml mixed with enteral feeding or placebo added to their formula. The primary efficacy outcome measure was the number of days required to achieve full enteral feeding. Safety outcomes included adverse events and blood glucose levels. RESULTS The study consisted of 33 infants randomized for the safety population and 31 for efficacy analysis. The mean time to full enteral feeding was 6.37 days (95% confidence interval [95%CI] 4.59-8.15) in the enteral rh-insulin treatment group (n=16) and 8.00 days (95%CI 6.20-9.80) in the placebo group (n=15), which represents a statistically significant reduction of 1.63 days (95%CI 0.29-2.97; P = 0.023). There was no difference in blood glucose levels between the groups and none of the participants experienced hypoglycemia. Adverse events occurred in 9/17 (53%) infants in the enteral rh-insulin group and 12/16 (75%) in the placebo group. CONCLUSIONS Our trial demonstrated that administration of enteral rh-insulin as supplement to enteral nutrition significantly reduced time to achieve full enteral feeding in preterm infants with a gestational age of 26-33 weeks.
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Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences.
McLeish, J, Alderdice, F, Robberts, H, Cole, C, Dorling, J, Gale, C, ,
Archives of disease in childhood. Fetal and neonatal edition. 2021;(3):244-250
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Abstract
BACKGROUND More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form. OBJECTIVE To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials. METHODS A qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis. SETTING Eleven neonatal units in England. PARTICIPANTS Eleven parents and ten health professionals with experience of simplified consent. RESULTS Five themes emerged: 'opt-out consent operationalised as verbal opt-in consent', 'opt-out consent normalises participation while preserving parental choice', 'opt-out consent as an ongoing process of informed choice', 'consent without a consent form' and 'choosing to opt out of a comparative effectiveness trial', with two subthemes: 'wanting "normal care"' and 'a belief that feeding is better'. CONCLUSION Introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as 'opt-out' can help to normalise participation and emphasise that parents can withdraw consent.
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Comparison of norepinephrine, dopamine and dobutamine combined with enteral nutrition in the treatment of elderly patients harboring sepsis.
Zhou, WJ, Cui, JK, Liu, M, Shang, XK, Ding, SS
Pakistan journal of pharmaceutical sciences. 2021;(3):957-961
Abstract
The present study was performed in order to investigate the safety and efficacy of different vasoactive drugs combined with enteral nutrition in terms of treating elderly patients with sepsis. A total of 75 elderly patients with sepsis treated with enteral nutrition in our hospital were randomly divided into three groups: group A (n = 25), group B (n = 25) and group C (n = 25). The three groups were treated with dopamine, dobutamine and norepinephrine respectively. One week after treatment, the therapeutic effects of the three groups were compared, the vascular elastic indexes, hemodynamic indexes and levels of inflammatory factors of the three groups were measured. After treatment, the clinical effective rate of group C was evidently higher than that of group A and group B. The vascular elasticity coefficient and stiffness coefficient in group C were significantly lower than those in group A and group B, and the arterial compliance in group C was significantly higher than that in group A and group B (P < 0.05). The levels of MAP and PVRI in group C were significantly higher than those in group A and B, and the levels of CI, CVP and HR in group C were significantly lower than those in group A and group B (P < 0.05). Norepinephrine elicited greater effects in terms of improving hemodynamic indexes, vascular elasticity and reducing the level of inflammatory factors compared with dopamine and dobutamine in elderly patients harboring sepsis.
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The efficacy of early postoperative enteral immunonutrition on T-lymphocyte count: A randomised control study in low-risk cardiac surgery patients.
Svetikiene, M, Ringaitiene, D, Vezeliene, J, Isajevas, V, Trybe, D, Vicka, V, Malickaite, R, Jurgauskiene, L, Norkuniene, J, Serpytis, M, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(2):372-379
Abstract
BACKGROUND Patients undergoing cardiac surgery have a pronounced immune response that leads to a reduction in cellular immunity. Immune-modulating nutritional supplements are considered to be beneficial for patients undergoing major surgery. However, due to the lack of studies in the cardiac surgery population, the effect of immunonutrition remains unclear in this patient group. OBJECTIVE Our purpose was to research the efficacy of early postoperative enteral immunonutrition on T-lymphocyte count in the cardiac surgery population. METHODS This was a randomised control study of low operative risk adult patients, who underwent elective cardiac surgery. These patients were randomised into immunonutrition and control groups. The immunonutrition group was supplemented with immune nutrients for five postoperative days. The counts of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell subpopulations were determined on the day of surgery and on the sixth postoperative day. RESULTS Fifty-five patients were enrolled in the study, the mean age was 69.7 ± 6.3 years, 28 (50.9%) of them were males, the median operative risk was 1.75%. Twenty-seven (49.1%) were randomised into the immunonutrition group. The control and the immunonutrition groups were similar before the intervention. The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56 (∗109/l), p = 0.035 and 1.02 ± 0.36 vs. 0.80 ± 0.43 (∗109/l), p = 0.048, respectively. Regression analysis was performed to determine the efficacy of the immunonutrition on the counts of the CD3+ and CD4+ T cells; CD3+ T and CD4+ T cell counts were increased to 0.264 (∗109/l), p = 0.039 and 0.232 (∗109/l), p = 0.021, respectively. CONCLUSIONS Early postoperative immunonutrition increases the count of the CD3+ and CD4+ T cells in cardiac surgical patients. Clinical trials identifier number: NCT04047095.
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Cortical Oxygenation Changes during Gastric Tube Feeding in Moderate- and Late-Preterm Babies: A NIRS Study.
Muelbert, M, Alexander, T, Pook, C, Jiang, Y, Harding, JE, Bloomfield, FH
Nutrients. 2021;(2)
Abstract
Smell and taste of food can trigger physiological responses facilitating digestion and metabolism of nutrients. Controlled experimental studies in preterm babies have demonstrated that smell activates the orbitofrontal cortex (OFC) but none have investigated the effect of taste stimulation. Using cotside Near-Infrared Spectroscopy (NIRS), we measured changes in OFC cerebral oxygenation in response to gastric tube feeds five and 10 days after birth in 53 assessments of 35 moderate- to late-preterm babies enrolled in a randomized trial. Babies were randomly assigned to receive smell and taste of milk before gastric tube feeds (intervention group, n = 16) or no exposure (control group, n = 19). The majority of babies were born at 33 weeks of gestation (range 32-34) and 69% were boys. No differences in OFC cerebral oxygenation were observed between control and intervention groups. Gastric tube feeds induced activation of the OFC (p < 0.05), but sensory stimulation alone with smell and taste did not. Boys, but not girls, showed activation of the OFC following exposure to smell of milk (p = 0.01). The clinical impact of sensory stimulation prior to tube feeds on nutrition of preterm babies, as well as the impact of environmental inputs on cortical activation, remains to be determined.
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Prospective Randomized Trial of Early Postoperative Enteral and Total Parenteral Nutrition for Treating Esophageal Cancer.
Hamai, Y, Hihara, J, Emi, M, Ibuki, Y, Kurokawa, T, Yoshikawa, T, Hirohata, R, Ohsawa, M, Kitasaki, N, Okada, M
Anticancer research. 2021;(12):6237-6246
Abstract
BACKGROUND/AIM: Surgical stress significantly decreases serum diamine oxidase (DAO), a marker of intestinal mucosal maturation and integrity. This study aimed to determine the effects of postoperative enteral and total parenteral nutrition (EN and TPN, respectively) in patients with esophageal cancer. PATIENTS AND METHODS This prospective randomized trial compared serum DAO activities, nutritional states, trace elements and complications between patients who underwent esophagectomy and received EN or TPN for seven days thereafter. RESULTS Fifty-one patients were randomized to receive EN or TPN. The rates of change in serum DAO activity from the day before surgery were 0.79, 0.89 and 0.91 on postoperative days (POD) 1, 3 and 7, respectively, in the EN group, and 0.64, 0.76 and 1.06, respectively, in the TPN group, with no significant differences. Furthermore, the rates of changes in indicators of nutritional status, namely total protein, albumin, total cholesterol, trace element concentrations and infectious and non-infectious complications did not significantly differ between the groups. CONCLUSION EN and/or TPN can be administered for early nutritional management until resumption of oral intake after esophagectomy according to the postoperative status of individual patients with esophageal cancer.
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A multicenter randomized clinical trial of pharmacological vitamin B1 administration to critically ill patients who develop hypophosphatemia during enteral nutrition (The THIAMINE 4 HYPOPHOSPHATEMIA trial).
Deane, AM, Jiang, A, Tascone, B, Clancy, A, Finnis, ME, Collie, JT, Greaves, R, Byrne, KM, Fujii, T, Douglas, JS, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(8):5047-5052
Abstract
BACKGROUND Hypophosphatemia may be a useful biomarker to identify thiamine deficiency in critically ill enterally-fed patients. The objective was to determine whether intravenous thiamine affects blood lactate, biochemical and clinical outcomes in this group. METHOD This randomized clinical trial was conducted across 5 Intensive Care Units. Ninety critically ill adult patients with a serum phosphate ≤0.65 mmol/L within 72 h of commencing enteral nutrition were randomized to intravenous thiamine (200 mg every 12 h for up to 14 doses) or usual care (control). The primary outcome was blood lactate over time and data are median [IQR] unless specified. RESULTS Baseline variables were well balanced (thiamine: lactate 1.2 [1.0, 1.6] mmol/L, phosphate 0.56 [0.44, 0.64] mmol/L vs. control: lactate 1.0 [0.8, 1.3], phosphate 0.54 [0.44, 0.61]). Patients randomized to the intervention received a median of 11 [7.5, 13.5] doses for a total of 2200 [1500, 2700] mg of thiamine. Blood lactate over the entire 7 days of treatment was similar between groups (mean difference = -0.1 (95 % CI -0.2 to 0.1) mmol/L; P = 0.55). The percentage change from lactate pre-randomization to T = 24 h was not statistically different (thiamine: -32 (-39, -26) vs. control: -24 (-31, -16) percent, P = 0.09). Clinical outcomes were not statistically different (days of vasopressor administration: thiamine 2 [1, 4] vs. control 2 [0, 5.5] days; P = 0.37, and deaths 9 (21 %) vs. 5 (11 %); P = 0.25). CONCLUSIONS In critically ill enterally-fed patients who developed hypophosphatemia, intravenous thiamine did not cause measurable differences in blood lactate or clinical outcomes. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry (ACTRN12619000121167).
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Effect of Aspiration and Evaluation of Gastric Residuals on Intestinal Inflammation, Bleeding, and Gastrointestinal Peptide Level.
Parker, LA, Weaver, M, Murgas Torrazza, RJ, Shuster, J, Li, N, Krueger, C, Neu, J
The Journal of pediatrics. 2020;:165-171.e2
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Abstract
OBJECTIVE To determine the effect of gastric residual aspiration and evaluation on preterm very low birth weight infants' gastrointestinal function, intestinal inflammation, and gastrointestinal mucosal bleeding. STUDY DESIGN This single-center, randomized trial compared omission of gastric residuals vs prefeed gastric residuals in 143 infants ≤32 weeks of gestation with a birthweight of ≤1250 g for 6 weeks after birth. Serum levels of gastrin and motilin were collected between 14 and 21 days of life. Stools were collected at 3 and 6 weeks of age and analyzed for calprotectin and S100A12 levels. All stools were tested for occult blood for 6 weeks. RESULTS Means for gastrin (P = .999) and motilin (P = .694) were similar between groups and there were no statistically significant differences in adjusted means for transformed calprotectin (P = .580), and S100A12 (P = .212). Both calprotectin (P = .003) and S100A12 (P = .002) increased from week 3 to week 6. The mean percentage of stools positive for occult blood (P = .888) were similar between the groups. CONCLUSIONS Gastrointestinal function, intestinal inflammation, and gastrointestinal mucosal bleeding were similar whether aspiration and evaluation of gastric residuals were eliminated or not, suggesting routinely evaluating gastric residuals before every feeding may be unnecessary. TRIAL REGISTRATION CLINICALTRIALS.GOV:: NCT01863043.
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Effect of Intermittent or Continuous Feed on Muscle Wasting in Critical Illness: A Phase 2 Clinical Trial.
McNelly, AS, Bear, DE, Connolly, BA, Arbane, G, Allum, L, Tarbhai, A, Cooper, JA, Hopkins, PA, Wise, MP, Brealey, D, et al
Chest. 2020;(1):183-194
Abstract
BACKGROUND Acute skeletal muscle wasting in critical illness is associated with excess morbidity and mortality. Continuous feeding may suppress muscle protein synthesis as a result of the muscle-full effect, unlike intermittent feeding, which may ameliorate it. RESEARCH QUESTION Does intermittent enteral feed decrease muscle wasting compared with continuous feed in critically ill patients? STUDY DESIGN AND METHODS In a phase 2 interventional single-blinded randomized controlled trial, 121 mechanically ventilated adult patients with multiorgan failure were recruited following prospective informed consultee assent. They were randomized to the intervention group (intermittent enteral feeding from six 4-hourly feeds per 24 h, n = 62) or control group (standard continuous enteral feeding, n = 59). The primary outcome was 10-day loss of rectus femoris muscle cross-sectional area determined by ultrasound. Secondary outcomes included nutritional target achievements, plasma amino acid concentrations, glycemic control, and physical function milestones. RESULTS Muscle loss was similar between arms (-1.1% [95% CI, -6.1% to -4.0%]; P = .676). More intermittently fed patients received 80% or more of target protein (OR, 1.52 [1.16-1.99]; P < .001) and energy (OR, 1.59 [1.21-2.08]; P = .001). Plasma branched-chain amino acid concentrations before and after feeds were similar between arms on trial day 1 (71 μM [44-98 μM]; P = .547) and trial day 10 (239 μM [33-444 μM]; P = .178). During the 10-day intervention period the coefficient of variation for glucose concentrations was higher with intermittent feed (17.84 [18.6-20.4]) vs continuous feed (12.98 [14.0-15.7]; P < .001). However, days with reported hypoglycemia and insulin usage were similar in both groups. Safety profiles, gastric intolerance, physical function milestones, and discharge destinations did not differ between groups. INTERPRETATION Intermittent feeding in early critical illness is not shown to preserve muscle mass in this trial despite resulting in a greater achievement of nutritional targets than continuous feeding. However, it is feasible and safe. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT02358512; URL: www.clinicaltrials.gov.