Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

NewGiza University

Status: Unknown

Conditions: Critical Illness; Sepsis

Treatments: Dietary Supplement: Neo Mune

Study type: Interventional

Funder types: Other

Identifiers

NCT05186480

NewGizaU

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

test group

Active Comparator group

Description:

they receive the immune enhancing formula

Treatment:

Dietary Supplement: Neo Mune

control group

No Intervention group

Description:

they receive the conventional formula