ABSTRACT
INTRODUCTION: Several side effects within the patients undergoing hematopoietic stem cell transplantation (HSCT), especially ones that influence nutrition intake, can cause weight loss and malnutrition. Based on studies, oral nutritional supplement (ONS) may reinforce their nutrient intake and progress clinical outcomes. The objective of this research is to investigate the effect of oral nutrition supplements on the nutritional and clinical status of patients undergoing autologous hematopoietic stem cell transplantation. METHODS: After block randomization used the website www.randomization , 38 patients will be enrolled in this study, patients will be allocated to the intervention (ONS) or control groups in a 1: 1 ratio. Patients in the ONS group will receive 250 ml of standard formula (Ensure®, Abbott Nutrition) which has 14-15% protein twice a day, in the morning and bedtime snacks for 21 days. All the procedures done in the control group will be the same as the ONS group except receiving ONS. We will examine the outcomes include; weight, appetite, hand grip strength, calf circumference, mid-arm circumference, total energy intake, protein intake, carbohydrate intake, fat intake, severity of oral mucositis, rate of infection during hospitalization, graft failure, recurrence rate after transplantation, the number of days it takes for neutrophil and platelet engraftment to occur, number of readmissions after transplantation during three months, mortality rate up to three months after transplantation and the three-day food diary record; all the evaluations will be carried out in three steps; 7 days before transplant, on the 14th day after transplantation, and on the 90th day after the transplantation. DISCUSSION: These patients' weight loss and malnourishment are significant concerns. The use of ONS in patients receiving HSCT has not been the subject of any research. TRIAL REGISTRATION: This clinical trial was registered in Iranian Registry of Clinical Trials ( http://www.irct.ir ) on 2022-12-09 with the code number IRCT20220208053971N2.
ABSTRACT
We conducted an umbrella review to summarize the existing evidence on the effect of early enteral nutrition (EEN) compared with other approaches, including delayed enteral nutrition (DEN), parenteral nutrition (PN), and oral feeding (OF) on clinical outcomes in hospitalized patients. We performed a systematic search up to December 2021, in MEDLINE (via PubMed), Scopus, and Institute for Scientific Information Web of Science. We included systematic reviews with meta-analyses (SRMAs) of randomized trials investigating EEN compared with DEN, PN, or OF for any clinical outcomes in hospitalized patients. We used "A Measurement Tool to Assess Systematic Reviews" (AMSTAR2) and the Cochrane risk-of-bias tool for assessing the methodological quality of the systematic reviews and their included trial, respectively. The certainty of the evidence was rated using the "Grading of Recommendations Assessment, Development, and Evaluation" (GRADE) approach. We included 45 eligible SRMAs contributing with a total of 103 randomized controlled trials. The overall meta-analyses showed that patients who received EEN had statistically significant beneficial effects on most outcomes compared with any control (ie, DEN, PN, or OF), including mortality, sepsis, overall complications, infection complications, multiorgan failure, anastomotic leakage, length of hospital stay, time to flatus, and serum albumin levels. No statistically significant beneficial effects were found for risk of pneumonia, noninfectious complications, vomiting, wound infection, as well as number of days of ventilation, intensive care unit days, serum protein, and pre-serum albumin levels. Our results indicate that EEN may be preferred over DEN, PN, and OF because of the beneficial effects on many clinical outcomes.