Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

Not Applicable

• Conditions: Sepsis; Critical Illness
• Interventions: Dietary Supplement: Neo Mune

• Registration Number: NCT05186480
• Lead Sponsor: NewGiza University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-03
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-12-23
• Status Verified: 2022-01
• Study First Posted: 2022-01-11
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	Neo Mune	they receive the immune enhancing formula

Primary Outcome Measures

Name	Time	Method
oxygen supply	28 days	arterial blood gases
inflammatory markers	28 days	C-Reactive protein
severity of disease classification	28 days	acute physiology and chronic health evaluation score
immune profile	28 days	C-Reactive protein
critical care need	28 days	days on oxygen supply
fluid status	28 days	albumin
Intensive Care Unit mortality	28 days	The Sequential Organ Failure Assessment score

Trial Locations

Locations (1)

NewGizaU; 🇪🇬 Cairo, Egypt