Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

NCT ID: NCT05186480

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-03

Study Completion Date

2022-03-28

Brief Summary

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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

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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.

Conditions

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Sepsis Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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test group

they receive the immune enhancing formula

Group Type ACTIVE_COMPARATOR

Neo Mune

Intervention Type DIETARY_SUPPLEMENT

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)

control group

they receive the conventional formula

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NewGiza University

OTHER

Sponsor Role lead

Responsible Party

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Rana Muhammed

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nada H Farrag, Msc

Role: STUDY_DIRECTOR

NewGiza University (NGU)- School of Pharmacy

Locations

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NewGizaU

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nada Farrag, MSc

Role: CONTACT

00201002092625

Manal Maher, PhD

Role: CONTACT

Facility Contacts

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Rana Muhammed

Role: primary

+201022091805

Other Identifiers

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NewGizaU

Identifier Type: -

Identifier Source: org_study_id

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