Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Critical Illness
• Intervention / Treatment: Dietary supplement: Neo Mune

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada Farrag, MSc; Phone Number: 00201002092625; Email: nada.farrag@ngu.edu.eg
• Study Contact Backup: Name: Manal Maher, PhD; Email: Mmaher@ngu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • NewGizaU
    • Contact: Rana Muhammed; Phone Number: +201022091805; Email: rana.abdulmoneam@ngu.edu.eg
    • Principal Investigator: Rana Nasr, Bsc
    • Sub-Investigator: Lamia El wakeel, PhD
    • Sub-Investigator: Nada Farrag, MSc
    • Sub-Investigator: Ahmed Essam, Bsc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: test group; they receive the immune enhancing formula	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)
No Intervention: control group; they receive the conventional formula

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NewGiza University
• Investigators: Study Director: Nada H Farrag, Msc, NewGiza University (NGU)- School of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 28, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: malnutrition; immune modulating formula
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Critical Illness
• Other Study ID Numbers: NewGizaU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No