Enteral Delivery of Pravastatin Sodium Tablets: Effect of Compounding into a Liquid Form and Co-Administration of Enteral Nutrition.

BACKGROUND: Compounding solid oral dosage forms into liquid preparations is a common practice for administering drug therapy to patients with swallowing difficulties. This is particularly relevant for those on enteral nutrition, where factors such as the administration procedure and co-administration of enteral nutrition play crucial roles in effective drug delivery. Due to the limited studies focused on this practice, the impact of co-administered nutrition remains unclear. METHODS: Pravastatin tablets were compounded into two liquid formulations and administered through three independent tubes for ten cycles. The drug amount was quantified upstream and downstream of the tubes both with and without different (fiber content) nutritional boluses. RESULTS: The compounding procedure did not lower the drug amount with respect to the original tablets. However, when the liquid formulation was pumped through the tubes, a statistically significant reduction in the pravastatin administered (between 4.6% and 11.3%) was observed. The co-administration of different nutritional boluses or the compounding procedure did not affect the general results. CONCLUSIONS: Pravastatin loss appears unavoidable when administered via the enteral tube. Although, in this case, the loss was of limited clinical relevance, it is important not to underestimate this phenomenon, especially with drugs having a narrow therapeutic index.

Nutrition support management of organ transplant recipients in the acute posttransplant phase.

Patients who undergo solid organ transplant can have an extensive and challenging postoperative course. The chronicity of the disease state prior to transplant in combination with transplant-specific complications and immunosuppressant medications can lead to distinct challenges that are not observed in other critically ill patients. Although the manifestation of posttransplant complications may be specific to the organ being transplanted, there are common transplant challenges that affect nutrition therapy in these patients. Effects of malnutrition, metabolic aberrations, and posttransplant organ dysfunction should be considered when developing a nutrition care plan for patients in the immediate posttransplant phase. This article addresses the various complications that can arise in the immediate posttransplant phase among patients undergoing solid organ transplant and the appropriate nutrition interventions or considerations for this specialized patient population.

Nutrition support in the pediatric total pancreatectomy with islet autotransplantation recipient.

For children with diminished quality of life and chronic pain caused by acute recurrent or chronic pancreatitis who are undergoing total pancreatectomy with islet autotransplantation, postoperative nutrition support has several unique characteristics. Surgical complications may lead to delays in nutrition support initiation or require modifications to the regimen. Early postoperative dysmotility requires the use of temporary enteral nutrition until this improves. The resultant complete exocrine pancreatic insufficiency necessitates lifelong pancreatic enzyme replacement therapy and fat-soluble vitamin supplementation. A low-oxalate diet is recommended to prevent kidney stones. Carbohydrate counting is needed for the provision of short-term insulin dosing and possibly long-term as well, depending on the transplanted islet yield. Children should have careful nutrition assessment and monitoring at several follow-up visits during the first year, then annually, and at any time with concerns.

Current topics in pediatric enteral nutrition safety.

Enteral nutrition is a cornerstone of nutrition support therapy in patients of all ages and across the care continuum. Safe delivery of enteral nutrition to patients is paramount. This review article will focus on current topics in enteral nutrition safety primarily in children including safety with home-made blenderized feeds, recent infant and enteral formula shortages largely due to formula contamination at the manufacturer level, and concerns with importing infant formulas.

Effect of blenderized tube feeds on gastric emptying: A retrospective cohort study.

BACKGROUND: Blenderized tube feeds (blends) are associated with lower hospital admissions and reduced gastroesophageal symptoms, but their high viscosity may theoretically prolong gastric emptying. Our objective was to compare differences in gastric emptying with blends vs with formula. METHODS: We retrospectively identified individuals 6 months to 20 years with enteral tubes who underwent 1-h liquid gastric emptying scintigraphy from 1998 to 2020 at Boston Children's Hospital. Examinations were excluded if a postpyloric tube was present, tracer was administered orally or with diet differing from habitual, habitual diet was indeterminable, imaging was terminated early, or >50% of input counts emptied during bolus administration. Emptying was classified as delayed if gastric residual at 1 h was ≥60% of ingested dose. RESULTS: Eighteen examinations (15 individuals) were performed with blends and 35 examinations (32 individuals) with formula. Although percentage of residual at 1 h was significantly higher in patients receiving blends compared with formula (54 ± 17 vs 40 ± 25, P = 0.04), the number of patients with delayed gastric emptying did not differ (39% vs 29%, respectively, P = 0.54). Type of diet, feed volume or concurrent medications did not predict delayed gastric emptying. Children with blends received higher bolus volumes (106 ± 55 vs 66 ± 59 ml; P = 0.02), and this significantly predicted percentage of residual (ß = 0.14; P = 0.01). CONCLUSION: The proportion of patients with delayed gastric emptying was similar in children receiving blends and formula. Although the mean percentage of gastric residual was higher with blends, this may be explained by higher bolus volumes administered. This preliminary work suggests that blends compare favorably to formula.

Home enteral nutrition: A descriptive study.

BACKGROUND: With data demonstrating benefit, the prevalence of home enteral nutrition (HEN) has increased significantly over the last few decades. Despite this increase, there remains a paucity of data regarding real-world use of HEN including clinical outcomes and complications. METHODS: Descriptive analysis of prospectively maintained database of our specialized HEN program was undertaken. Patients who received care in our program with HEN initiation date between January 1, 2018, and December 31, 2020, were included in the analysis. Data regarding demographic information, anthropometrics, enteral nutrition (EN) regimen, electrolytes, and nutrition therapy history were included and tracked until July 31, 2021. RESULTS: During the study period, 1600 patients initiated HEN treatment under our care. Majority of the study population needed EN therapy due to malignancy and its complications, including malignant dysphagia or mechanical obstruction (60.6%) followed by neurodegenerative diseases (7.5%). By the end of the study period, a majority of the patients (82%) stopped HEN treatment. Of these, 44.2% achieved EN goals and/or oral autonomy. Patients continued HEN treatment for a median of 100 (interquartile range, 32-301) days. Overall, 53.2% of patients experienced/reported at least one HEN-related complication that was clinically managed by the HEN team. Complications included tube-related, enteral feeding intolerance (EFI), and electrolyte shifts. CONCLUSION: In our study population, HEN was most utilized to manage malignancy-related complications, including dysphagia. Unfortunately, complications, including EFI and tube-related complications, remained quite prevalent. Further evaluation regarding risk factors for complications and preventive mechanisms, such as increased education, is indicated.

Enteral nutrition product formulations: A review of available products and indications for use.

When oral nutrition is not feasible, enteral nutrition (EN) therapy is often considered the preferred route of nutrition support to meet the nutrient needs of individuals with a functional gastrointestinal tract across multiple levels of care (critical care, acute care, and home care). Enteral formulations have progressively evolved over the last 50 years from the simple blending of hospital food thin enough to run through a feeding tube, to the development of commercial standard formulas, followed by specialized formulas with immune-modulating and disease-specific qualities, to the most recent shift to food-based or blenderized EN composed of natural, whole foods with perceived health benefits. With the vast number of enteral formulations on the market, clinicians may be overwhelmed trying to determine proven vs theoretical benefits. This review is intended to explore differences in enteral formulations, identify implications for clinical practice, and review evidenced-based clinical guidelines to assist clinicians in enteral formula selection.

Pediatric formulas: Categories, composition, and considerations.

Formulas, liquid nutrition, may be consumed orally or via a feeding tube to provide partial or complete nutrition that a given individual could not obtain using natural food stuffs in their native form. A wide range of commercially available formulas exist, which may be used as sole-source nutrition or in conjunction with other foods. Physicians and dietitians must understand the nature of and indications for specific formulas to treat diseases, provide complete nutrition to patients, and avoid harm. Products vary in macronutrient and micronutrient content and calorie concentration among many other factors. They are formulated specifically for patients of specific ages, correlating to nutritional needs and medical diagnoses. Additionally, formula availability, insurance coverage, mode of consumption, physiologic tolerance, and caregiver preference influence formula selection. Caregivers may also make their own pediatric formulas. We review commercial and homemade pediatric formulas.

Stability of vitamin A, E, C and thiamine during storage of different powdered enteral formulas.

In this study, two different kinds of commercial enteral formulas were selected to evaluate the changes of vitamin A, E, C and thiamine during the different storage conditions of different temperature and relative humidity (60 ± 1 °C, 60 ± 5% for 5 and 10 days; 37 ± 1 °C, 75 ± 5% for 1, 2, 3, 5 and 6 months; 25 ± 1 °C, 60 ± 5% for 3, 6, 9, 12, 18 and 24 months). The results showed that as the temperature or time increased, the content of vitamin A, E and thiamine was gradually decreased whilst the level of vitamin C remained stable. The vitamins exhibited more stability at the storage of 25 ± 1 °C, RH 60 ± 5%. Vitamin A and thiamine decreased more in the polymeric formula (EFA) than that in the oligomeric formula (EFB), while, vitamin E decreased less in EFA than that in EFB. The kinetics of vitamin A, E and thiamine degradation during storage followed first order kinetic equations. Furthermore, the final levels of vitamins were higher than the minimum level recommended by legislation.

Foods for Special Medical Purposes in Home Enteral Nutrition-Clinical Practice Experience. Multicenter Study.

Background: Enteral nutrition (EN) with foods for special medical purposes (FSMP) is recommended for most patients on home enteral nutrition (HEN). Although there are disease-specific guidelines for energy, protein, and micronutrient provision, only a few studies are showing real-life experience in the long-term use of FSMP. Methods: In a multicenter study, the influence of the FSMP composition and administration technique (bolus vs. continuous) on protein and energy provision in HEN was analyzed. Provision of vitamins and minerals was compared to recommended daily allowance (RDA) and upper tolerable limit (UL). Results: Approximately, 772 patients on HEN, mostly (88.6%) with oncological and neurological diseases, were enrolled. The patients on standard FSMP received less protein and energy than those on hypercaloric and protein enriched despite receiving higher volumes of EN (p < 0.05). No differences were observed in jejunal feeding with oligomeric vs. polymeric FSMP in terms of energy, protein, and volume. Continuous gastric feeding provided more protein, energy, and volume vs. bolus feeding (p < 0.05). Significant number of patients received less than 100% RDA of vitamin D (50.5%), vitamin B3 (49%), vitamin K (21.8%), vitamin B5 (64.3%), vitamin B9 (60%). Majority of the patients received less than 100% RDA of sodium (80.2%), potassium (99%), chloride (98%), calcium (67%), magnesium (87%), fluoride (99%), and iodine (43%). Approximately, 43.63% of cancer and 49.9% of neurological patients received less than 1 g/kg/day of protein and 51.7% of cancer and 55.5% of neurological patients received less than 25 kcal/kg/day. Conclusion: Awareness of the available compositions of FSMP and advantageous profiles of specific diets may lead to the implementation of recommendations for EN. HEN professionals need to analyze all the patient's needs and requirements to provide more tailored matching of nutritional support.

Relationship between nutritional treatment compliance and nutritional status improvements in patients with gastrointestinal impairment taking an oral peptide-based supplement.

OBJECTIVES: Compliance in outpatients with gastrointestinal (GI) malabsorption is key in nutritional treatment. The objective of this study was to assess compliance in patients with GI impairment and malnutrition taking a high-calorie, high-protein, peptide-based oral nutritional supplement (ONS-PBD). METHODS: A prospective, multicenter, observational study was conducted in 19 medical sites in Spain where ONS-PBD were prescribed as standard of care. Patients consumed ONS-PBD daily for 12 wk. Compliance was calculated as the percentage consumed of the prescribed amount of ONS per day. RESULTS: A total of 90 adult patients were included in the study, of whom 64 completed the 12-wk regimine. Mean compliance was 78.8% ± 24.5%. Risk of malnutrition decreased in 56.3% of patients at 12 wk, as measured with the malnutrition universal screening tool. A reduction in abdominal pain was observed and stool consistency improved, with a mean of 54.7% and 27.5%, respectively. Improvements in quality of life and a decrease in percentage of patients with severe functional impairment were observed. CONCLUSIONS: These data show that ONS-PBD compliance in malnourished patients with GI symptoms is high, reducing GI symptoms and improving patients' nutritional status.

Necrotizing enterocolitis in the preterm: newborns medical and nutritional Management in a Single-Center Study.

Necrotizing enterocolitis (NEC) is a typical disorder of preterm newborns, with a high mortality and morbidity rate. The therapeutic and nutritional management of disease depends on several factors. Its prognosis is linked, in addition to the severity of the disease and the need for surgery, to a correct enteral feeding in these patients. This study aims to identify the clinical characteristics of 18 patients with NEC, evaluating the different therapeutic paths undertaken, the type of formula used and the survival rate of this population. Average time of enteral nutrition before the NEC onset was 11,3 ± 11,6 days, with an average fasting period since the onset of 24 ± 18.9 days. 77.8% of patients received surgery and resumed enteral nutrition 17.7 ± 17.9 days after the intervention. The overall survival rate of our cohort was 55.5%. More prospective studies are needed to evaluate the long-term outcomes of survived children with NEC.

Clinical Outcomes Associated With Commercial and Homemade Blenderized Tube Feedings: A Literature Review.

There is emerging evidence in the pediatric population that blenderized tube feeding (BTF) may improve gastrointestinal intolerance; however, not much is known about the impact of BTF on clinical outcomes in adults. This article presents a review of the literature published in the past 10 years that explored the impact of BTF on nutrition status (ie, weight status, body mass index, and upper-arm circumference) and nutrition adequacy in adults. The results indicate that BTF, compared with commercial enteral formula (CEF), may be inadequate in calories, macronutrients, and some micronutrients, given variability in BTF formula composition. As a result, BTF may result in significantly more weight loss than CEF. Thus, BTF may not be appropriate for adult patients who are malnourished or are at risk for malnutrition due to the potential worsening of clinical outcomes.

Reduction in Healthcare Utilization With Transition to Peptide-Based Diets in Intolerant Home Enteral Nutrition Patients.

BACKGROUND: Since the introduction of percutaneous endoscopic gastrostomy in the 1980s, the prevalence of home enteral nutrition (HEN) support has increased significantly. Despite these increases, many patients are unable to tolerate standard polymeric formulas (SPFs), resulting in significant healthcare resource utilization. Peptide-based diets (PBDs) have emerged as a viable option in SPF-intolerant patients; however, data in the HEN population are lacking. METHODS: Retrospective review of our prospectively maintained HEN database was conducted to assess tolerance, efficacy, and impact on healthcare utilization in patients on PBDs. RESULTS: From January 1, 2016, to May 1, 2018, 95 patients were placed on PBDs, with 53 patients being started directly and 42 patients being transitioned from SPFs. In patients transitioned to PBDs, symptoms of nausea and vomiting, diarrhea, abdominal pain, and distention improved significantly. Healthcare utilization also declined significantly, including mean number of phone calls (1.8 ± 1.6 to 1.1 ± 0.9, P = 0.006), mean number of emergency room visits (0.3 ± 0.6 to 0.09 ± 0.3, P = 0.015), and mean number of provider visits (1.3 ± 1.3 to 0.3 ± 0.5, P < 0.0001). CONCLUSIONS: Overall, PBDs were well tolerated and resulted in significant improvements in symptoms of gastrointestinal distress and healthcare utilization in patients intolerant to SPFs.

Determining Viscosity of Blenderized Formula: A Novel Approach Using the International Dysphagia Diet Standardisation Initiative Framework.

BACKGROUND: Blenderized formula (BF) can be used in place of standard enteral formula and is composed of blenderized whole foods and purees. Benefits of using BF include reduced vomiting and retching, in part related to a higher viscosity. Commercially prepared BFs vary significantly in viscosity when comparing available products. Viscosity can be measured using a viscometer, although this requires expensive and sophisticated equipment. We proposed an alternative method to describe viscosity of BFs using the International Dysphagia Diet Standardisation Initiative (IDDSI) framework. This flow test provides a simple and objective method to describe liquid thickness and requires only a 10-mL luer tip syringe and stopwatch. METHODS: Full-strength BFs were measured using the IDDSI flow test and compared with a standard enteral formula. BFs were then diluted until a slightly thick viscosity was achieved, which correlated to the viscosity of the reference formula. RESULTS: IDDSI flow-test results indicated that undiluted BFs ranged in viscosity, from slightly thick to extremely thick, when measured at room temperature. The volume of water required to achieve a slightly thick viscosity ranged from 0 to 270 mL per serving, resulting in a wide variation in dilution of formula. CONCLUSION: The IDDSI flow test was simple to perform and can serve as a tool to determine the viscosity of BFs.

Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: The toxic effect of chemotherapy on the gastrointestinal tract may lead to mucositis and is associated with the pathogenesis of other treatment-related complications. We hypothesized that nutrition supplementation with bovine colostrum, rich in bioactive factors, would ameliorate gastrointestinal toxicity and reduce the incidence of fever and infectious complications during induction treatment for childhood acute lymphoblastic leukemia (ALL). METHODS: Children with newly diagnosed ALL were included in a 2-center, randomized, double-blind, placebo-controlled clinical trial. Patients were randomized to receive a daily colostrum or placebo supplement during 4 weeks of induction treatment. Data on fever, bacteremia, need for antibiotics, and mucosal toxicity were prospectively collected. (Trial registration: www.clinicaltrials.gov NCT01766804). RESULTS: Sixty-two patients were included. No differences were found for the primary outcome (number of days with fever). No difference was observed for neutropenic fever, intravenous antibiotics, or incidence of bacteremia. Peak severity of oral mucositis was significantly reduced by colostrum (7/29 patients, 24% mild; 6/29, 21% moderate; 1/29, 3% severe) compared with placebo (12/31, 39% mild; 1/31, 3% moderate; 7/31, 23% severe) (P = 0.02). Among patients receiving at least 1 dose of supplement (colostrum: n = 22; placebo: n = 30), the peak weekly self-reported oral mucositis score was overall significantly less severe in the colostrum group (P = 0.009). CONCLUSION: The use of prophylactic bovine colostrum showed no effect on fever, infectious morbidity, or inflammatory responses. Nevertheless, these data may suggest protective effects on the oral mucosa during induction therapy in childhood ALL, encouraging additional studies confirming these findings.

Achieving Protein Targets in the ICU Using a Specialized High-Protein Enteral Formula: A Quality Improvement Project.

BACKGROUND: To meet protein needs in critical illness (CI), guidelines suggest ≥1.2-2.5 g protein/kg/d; however, most intensive care unit (ICU) patients receive ≤0.7 g/kg/d. Higher protein enteral nutrition (EN) formulas may be part of the solution to provide prescribed protein. Our objective was to demonstrate that an EN formula with 37% protein can deliver ≥80% of prescribed protein, without overfeeding calories within the first 5 days of feeding and to describe ICU clinicians' experience. METHODS: This quality improvement (QI) project included patients requiring exclusive EN for up to 5 days from 6 Canadian ICUs. Rationale for choosing formula, patient's BMI (kg/m2 ), nutrition targets, daily protein and energy delivered, feeding interruptions, and general tolerance were recorded. RESULTS: Forty-four of 49 patients received the formula ≥2 days. Average protein prescribed was 137.5 g/d (82.5-200) or 1.9 g/kg/d (1.5-2.5). Average protein delivered was 116.9 g/d (33.5-180) or 1.6 g/kg/d (0.4-2.4). Seventy-five percent to 83% of patients received ≥80% prescribed protein on days 2-5. Average energy prescribed was 1638.6 kcal/d (990-2500) or 17.8 kcal/kg (11-26). Average energy delivered was 1523.9 kcal/d (693.0-2557.5) or 17.3 kcal/kg/d (1.35-64.7). The formula was well tolerated with no gastrointestinal symptoms reported in 38 (86%) patients. The most common reasons to prescribe the formula were obesity and use of fat-based medications. CONCLUSIONS: We demonstrated in a QI study that a high-protein EN formula was tolerated in a small, heterogeneous group of ICU patients and effective in meeting protein targets without overfeeding.

Determination of glycemic index of enteral formulas used in clinical practice.

Glycemic Index (GI) is a measure of carbohydrate quality and is recognised as a valid and reproducible method of classifying carbohydrate foods according to its effects on postprandial glycaemia. In this randomised crossover trial (RBR-7rjx3k) we determined the GI of nine enteral formulas, following the Food and Agriculture Organisation/World Health Organisation method. Forty healthy participants were included in the study (85% female mean age 27.1 ± 6.7 years). GI of the enteral formulas ranged from 40.5 to 85.2; four formulas had high GI (Nutrienteral 1.5®, Novasource GI Control®, Diamax®, Isosource Soya®), two intermediate GI (Fresubin 1.2 HP Fibre®, Nutrison Energy Multifiber 1.5®) and three low GI (Trophic 1.5®, Glucerna®, Novasource GC HP®). The GI coefficient of variation ranged from 22.9% to 83.6%. The effect of the enteral formulas with low GI in glycemic control of patients with enteral nutrition prescription needs to be test in future studies.

Clinical Effects of a Pectin-Containing Oligomeric Formula in Tube Feeding Patients: A Multicenter Randomized Clinical Trial.

BACKGROUND: A pectin-containing oligomeric formula (POF) is a unique type of enteral formula that transforms from a liquid to a gel after reacting with gastric acid. Reports on its clinical effects have been limited. The present study was conducted to examine and verify the clinical effects of POF. METHODS: The study subjects were 201 stable patients receiving intragastric tube feeding. They were randomized into 2 groups to receive either POF or a standard polymeric formula (SPF) as a control. The duration of observation was 1 week. Analyses were conducted for the incidence of predefined composite events, including diarrhea, defecation treatments, and other enteral nutrition (EN) management-related events. RESULTS: Composite events occurred in 15 of 98 patients in the POF group and 30 of 100 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.011). In particular, diarrhea occurred in 2 patients in the POF group and 13 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.003). CONCLUSIONS: The results of this study suggest that POF is less likely to cause EN-related events, especially diarrhea, than SPF is.