Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

Sponsor

NewGiza University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05186480

Collaborator

(none)

Enrollment

Location

Arms

5.8

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sepsis Critical Illness	Dietary Supplement: Neo Mune	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 3, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 28, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NewGizaU	Cairo		Egypt

Sponsors and Collaborators

NewGiza University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rana Muhammed, Principle Investigator, NewGiza University

ClinicalTrials.gov Identifier:

NCT05186480

Other Study ID Numbers:

NewGizaU

First Posted:

Jan 11, 2022

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rana Muhammed, Principle Investigator, NewGiza University

malnutrition

immune modulating formula

Additional relevant MeSH terms:

Sepsis

Critical Illness

Study Results

No Results Posted as of Jan 19, 2022