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The aim is to compare the efficacy and tolerability of an immune modulating enteral nutrition formula versus the regular formula on the outcomes of critically ill septic patients by assessment of clinical outcomes, immune profile, tolerability and enteral nutrition intolerance and laboratory markers
Nutritional formulas are considered important sources of the dietary components that the body requires. They contain the sources of fats, proteins and carbohydrates and compensate any vitamin and mineral deficiency.
There is a special type of formulas called the "immune-enhancing formulas", they supplement the body not only with the energy sources but also, they boost the body's immune system as they contain multiple types of amino and fatty acids.
There is an ongoing debate around the efficacy of the immune-enhancing formulas, some studies show that they make a significant difference in enhancing the clinical outcomes compared to traditional formulas while other studies showed no significant difference between the traditional formulas and immune-enhancing formula.
The immune-enhancing nutritional formula is used in enteral and oral feeding for critically ill patients. It's mainly indicated in cases of malnutrition, post surgeries and traumas and immunocompromised patients.
Its composition:
Composition in approximate %w/w Maltodextrin 42.44% Sodium caseinate 18.25% MCT oil 6.28% Arginine 5.21% Poly-dextrose 4.00% Corn oil 3.48% Glutamine 2.61% Fish oil 2.32% Minerals 1.96% Vitamins 0.86% Artificial flavor (vanilla)
This study analyzed prospectively the clinical and laboratory outcomes of critically ill sepsis patients taking regular enteral nutrition versus immune modulating formulas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Active Comparator | they receive the immune enhancing formula |
|
| control group | No Intervention | they receive the conventional formula |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neo Mune | Dietary Supplement | Neo-mune is a nutritional formula used in enteral feeding for critically ill patients. It's mainly indicated in cases of malnutrition, post surgeries and traumas and immunocompromisation. Its composition: Composition in approximate %w/w Maltodextrin 42.44% Sodium caseinate 18.25% MCT oil 6.28% Arginine 5.21% Polydextrose 4.00% Corn oil 3.48% Glutamine 2.61% Fish oil 2.32% Minerals 1.96% Vitamins 0.86% Artificial flavor (vanilla) |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive Care Unit mortality | The Sequential Organ Failure Assessment score | 28 days |
| severity of disease classification | acute physiology and chronic health evaluation score | 28 days |
| critical care need | days on oxygen supply | 28 days |
| inflammatory markers | C-Reactive protein | 28 days |
| immune profile | C-Reactive protein | 28 days |
| fluid status | albumin | 28 days |
| oxygen supply | arterial blood gases | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nada Farrag, MSc | Contact | 00201002092625 | nada.farrag@ngu.edu.eg | |
| Manal Maher, PhD | Contact | Mmaher@ngu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nada H Farrag, Msc | NewGiza University (NGU)- School of Pharmacy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewGizaU | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D016638 | Critical Illness |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |