Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186480
• Other study ID #: NewGizaU
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2021
• Est. completion date: March 28, 2022

Study information

• Verified date: January 2022
• Source: NewGiza University
• Contact: Nada Farrag, MSc
• Phone: 00201002092625
• Email: nada.farrag[@]ngu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 28, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sepsis

Intervention

Dietary Supplement:
• Neo Mune
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)

Locations

Country	Name	City	State
Egypt	NewGizaU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
NewGiza University

Country where clinical trial is conducted

Egypt, 

Outcome

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