Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: March 1, 2022

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • Active Comparator: test group
    • they receive the immune enhancing formula
  • No Intervention: control group
    • they receive the conventional formula

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NewGiza University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rana Muhammed, Principle Investigator – NewGiza University
  • Overall Official(s)
    • Nada H Farrag, Msc, Study Director, NewGiza University (NGU)- School of Pharmacy
  • Overall Contact(s)
    • Nada Farrag, MSc, 00201002092625, nada.farrag@ngu.edu.eg

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