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.

Background Traumatic Brain Injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is a major problem among TBL patients which is in association with severity of illness and mortality in brain trauma patients, especially in subdural hemorrhage and epidural hemorrhage cases. A high percentage of adults admitted to the intensive care unit with critical conditions are diagnosed with vitamin D-deficiency, this deficiency may induce impaired immune responses and increase the risk of infections. Vitamin D intervention has been shown to modulate pro- and anti-inflammatory cytokines in non-critically ill patients, but to date, there is no substantial data on the effectiveness of vitamin D for the improvement of immune function in traumatic brain injury patients.Methods/design A randomized clinical trial (RCT) will be performed on 74 Iranian adults 18-65 years old with brain trauma, and will be treated daily by vitamin D supplements (100000 IU oral drop) or a similar placebo (1000 IU) for 5 days.Discussion If this randomized clinical trial elucidates reduction in inflammatory cytokines, it would provide the evidence for multi-central clinical trials to evaluate the efficacy of vitamin D supplementation in neuro -critically ill patients. Since vitamin D supplements are inexpensive and safe, this clinical trial could have the potential to improve clinical outcomes in traumatic brain injury patients through reduction of inflammation and infection associated morbidity and mortality rates.

Purpose The objective of this systematic review was to evaluate the effect of pre-, pro-, and synbiotics on feeding tolerance of enterally-fed critically ill adult patients. Methods Medline, Science Direct, Web of Knowledge, and the Cochrane Central Register of Controlled Trials were searched up to November 2019. English language randomized controlled trials reporting the effect of pre, pro or synbiotics on the feeding tolerance of enterally-fed critically ill adult patients were included. Results Among six studies reporting the energy intake, only two studies showed significantly higher energy intake in the prebiotic-receiving groups. Among four RCTs reporting frequency or time to achieve the target calorie, only one found a significant effect of probiotics to reduce the time to achieve a target dose of calorie. About the prevalence or duration of diarrhea, 7 out of 12 RCTs reported a beneficial effect. All but one study found no beneficial effects for gut microbiota manipulation on clinical endpoints including LOS in hospital and ICU. Conclusion It should be noticed that the heterogeneity in study designs, product format, and ICU patient populations makes it difficult to draw any general conclusion. Overall, it seems that pre, pro or synbiotics have not significant beneficial effect on feeding tolerance and clinical endpoints in critically ill adults, but they may reduce the prevalence or duration of diarrhea.

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.

Purpose: The objective of this systematic review was to evaluate the effect of pre-, pro-, and synbiotics on feeding tolerance of enterally-fed critically ill adult patients. Methods: Medline, Science Direct, Web of Knowledge, and the Cochrane Central Register of Controlled Trials were searched up to November 2019. English language randomized controlled trials reporting the effect of pre, pro or synbiotics on the feeding tolerance of enterally-fed critically ill adult patients were included. Results: Overall, 15 papers were selected for review. Among six studies reporting the energy intake, only two studies showed significantly higher energy intake in the prebiotic-receiving groups. Among four RCTs reporting frequency or time to achieve the target calorie, only one found a significant effect of probiotics to reduce the time to achieve a target dose of calorie. About the prevalence or duration of diarrhea, 7 out of 12 RCTs reported a beneficial effect. All but one study found no beneficial effects for gut microbiota manipulation on clinical endpoints including length of stay (LOS) in hospital and intensive care unit (ICU). Conclusion: It should be noticed that the heterogeneity in study designs, product format, and ICU patient populations makes it difficult to draw any general conclusion. Overall, it seems that pre, pro or synbiotics have not significant beneficial effect on feeding tolerance and clinical endpoints in critically ill adults, but they may reduce the prevalence or duration of diarrhea.