Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula Versus Regular Enteral Nutrition on the Outcome of Critically Ill Sepsis Patients. A Pilot Study

Conditions
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Sepsis, Critical Illness

Intervention / Treatment
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* Dietary Supplement: Neo Mune


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with sepsis according to guideline criteria AND Age ≥18 years Exclusion Criteria: Gastrointestinal tract complications or intestinal failure or any contraindications to receive enteral nutrition Hemodynamic instability on admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: test group<br>they receive the immune enhancing formula | Dietary Supplement: Neo Mune<br>* 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)<br>|
| No Intervention: control group<br>they receive the conventional formula | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, immune modulating formula