Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: study protocol and a review of previous studies
Abstract Background: Among critically ill patients, regardless of the heterogeneity of disease state, an extreme and persistent dysbiosis occurs. 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 macronutrients homeostasis disturbances. Methods: This is a prospective, single center, double-blind; a parallel randomized controlled trial that aimed to evaluate the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in critical care patients. All eligible patients (20 subjects in each group) will receive standard hospital gavage as enteral nutrition through a nasogastric tube (NGT) in the 24-48h after admission. In the intervention group, patients will receive Lactocare (ZistTakhmir) capsules 500 mg every 12h for 14 days. Patients in the control group will receive a placebo capsule which contains only the sterile maize starch and is similar to synbiotic capsules. The synbiotic and placebo capsules will be given through 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 ICU stay by improving energy and macronutrient homeostasis and reducing muscle protein catabolism. Trials registration: The trial protocol has been approved in Iranian Registry of Clinical Trials at 2019-03-17. The registration reference is IRCT20190227042857N1.