Abstract
Background
An extreme and persistent dysbiosis occurs among critically ill patients, regardless of the heterogeneity of disease. Dysbiosis in critically ill patients may make them prone to hospital-acquired infections, sepsis, multi-organ failure (MOF), energy homeostasis disturbance, muscle wasting, and cachexia. Modulation of gut microbiota through synbiotics can be considered as a potential treatment for muscle wasting and macronutrient homeostasis disturbances.
Methods
This is a prospective, single-center, double-blind, parallel randomized controlled trial with the aim to evaluate the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in critically ill patients. A total of 40 hemodynamically stable, adult, critically ill patients who receive enteral nutrition via a nasogasteric tube (NGT) in the 24–48 h after admission to critical care will be included in this study. Eligible patients will be randomly assigned to receive Lactocare (ZistTakhmir) capsules 500 mg every 12 h or a placebo capsule, which contains only the sterile maize starch and is similar to synbiotic capsules for 14 days. The synbiotic and placebo capsules will be given through the nasogastric tube, separately from gavage, after feeding.
Discussion
Gut microbiota modulation through synbiotics is proposed to improve clinical prognosis and reduce infectious complications, ventilator dependency, and length of ICU stay by improving energy and macronutrient homeostasis and reducing muscle protein catabolism.
Trial registration
Iranian Registry of Clinical Trials, IRCT20190227042857N1. Registered on 17 March 2019.
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Details
1 Mashhad University of Medical Sciences, Department of Nutrition, Medical School, Mashhad, Iran (GRID:grid.411583.a) (ISNI:0000 0001 2198 6209)
2 Mashhad University of Medical Sciences, Metabolic Syndrome Research Center, Mashhad, Iran (GRID:grid.411583.a) (ISNI:0000 0001 2198 6209)
3 Mashhad University of Medical Sciences, Department of community medicine, Medical School, Mashhad, Iran (GRID:grid.411583.a) (ISNI:0000 0001 2198 6209)
4 Mashhad University of Medical Sciences, Department of Anesthesiology, Mashhad, Iran (GRID:grid.411583.a) (ISNI:0000 0001 2198 6209)




