Clinical trial NCT05186480: Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Critical Illness
Keywords: malnutrition
immune modulating formula
Lead sponsor: NewGiza University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensive Care Unit mortality
timeFrame: 28 days
measure: severity of disease classification
timeFrame: 28 days
measure: critical care need
timeFrame: 28 days
measure: inflammatory markers
timeFrame: 28 days
measure: immune profile
timeFrame: 28 days
measure: fluid status
timeFrame: 28 days
measure: oxygen supply
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NewGizaU
Study officials:
affiliation: NewGiza University (NGU)- School of Pharmacy
name: Nada H Farrag, Msc
role: STUDY_DIRECTOR
References: