Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable sepsis
Started Oct 2021
Shorter than P25 for not_applicable sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2021
CompletedFirst Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2022
CompletedJanuary 19, 2022
January 1, 2022
5 months
October 28, 2021
January 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Intensive Care Unit mortality
The Sequential Organ Failure Assessment score
28 days
severity of disease classification
acute physiology and chronic health evaluation score
28 days
critical care need
days on oxygen supply
28 days
inflammatory markers
C-Reactive protein
28 days
immune profile
C-Reactive protein
28 days
fluid status
albumin
28 days
oxygen supply
arterial blood gases
28 days
Study Arms (2)
test group
ACTIVE COMPARATORthey receive the immune enhancing formula
control group
NO INTERVENTIONthey receive the conventional formula
Interventions
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)
Eligibility Criteria
You may qualify if:
- Diagnosed with sepsis according to guideline criteria AND
- Age ≥18 years
You may not qualify if:
- Gastrointestinal tract complications or intestinal failure or any contraindications to receive enteral nutrition
- Hemodynamic instability on admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NewGizaU
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nada H Farrag, Msc
NewGiza University (NGU)- School of Pharmacy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
October 28, 2021
First Posted
January 11, 2022
Study Start
October 3, 2021
Primary Completion
March 1, 2022
Study Completion
March 28, 2022
Last Updated
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share