Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula
Primary Purpose
Sepsis, Critical Illness
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Neo Mune
Sponsored by
About this trial
This is an interventional supportive care trial for Sepsis focused on measuring malnutrition, immune modulating formula
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
Sites / Locations
- NewGizaURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
test group
control group
Arm Description
they receive the immune enhancing formula
they receive the conventional formula
Outcomes
Primary Outcome Measures
Intensive Care Unit mortality
The Sequential Organ Failure Assessment score
severity of disease classification
acute physiology and chronic health evaluation score
critical care need
days on oxygen supply
inflammatory markers
C-Reactive protein
immune profile
C-Reactive protein
fluid status
albumin
oxygen supply
arterial blood gases
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05186480
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NewGiza University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Critical Illness
Keywords
malnutrition, immune modulating formula
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Active Comparator
Arm Description
they receive the immune enhancing formula
Arm Title
control group
Arm Type
No Intervention
Arm Description
they receive the conventional formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Neo Mune
Intervention Description
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)
Primary Outcome Measure Information:
Title
Intensive Care Unit mortality
Description
The Sequential Organ Failure Assessment score
Time Frame
28 days
Title
severity of disease classification
Description
acute physiology and chronic health evaluation score
Time Frame
28 days
Title
critical care need
Description
days on oxygen supply
Time Frame
28 days
Title
inflammatory markers
Description
C-Reactive protein
Time Frame
28 days
Title
immune profile
Description
C-Reactive protein
Time Frame
28 days
Title
fluid status
Description
albumin
Time Frame
28 days
Title
oxygen supply
Description
arterial blood gases
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada Farrag, MSc
Phone
00201002092625
Email
nada.farrag@ngu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Maher, PhD
Email
Mmaher@ngu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nada H Farrag, Msc
Organizational Affiliation
NewGiza University (NGU)- School of Pharmacy
Official's Role
Study Director
Facility Information:
Facility Name
NewGizaU
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana Muhammed
Phone
+201022091805
Email
rana.abdulmoneam@ngu.edu.eg
First Name & Middle Initial & Last Name & Degree
Rana Nasr, Bsc
First Name & Middle Initial & Last Name & Degree
Lamia El wakeel, PhD
First Name & Middle Initial & Last Name & Degree
Nada Farrag, MSc
First Name & Middle Initial & Last Name & Degree
Ahmed Essam, Bsc
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula
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