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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05186480
Other study ID # NewGizaU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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