Symbiotic supplementation effect oncritical care patients
Phase 3
- Conditions
- energy and macronutrient homeostasis disturbance- muscle wasting.Unspecified protein-calorie malnutrition
- Registration Number
- IRCT20190227042857N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Adults aged 18-65 years
ICU admission
stable hemodynamic within 24-48 hour after admission
requiring enteral nutrition(EN) via nasogastric tube (NGT) feeding
not taking any kind of microbial cell preparations (pre, pro, synbiotic)
providing the written consent
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Energy homeostasis. Timepoint: daily. Method of measurement: calorie intake- estimated calorie requirement.;Protein catabolism. Timepoint: 7, 14 days after intervention. Method of measurement: nitrogen balance.;Muscle protein turnover. Timepoint: 14 days after intervention. Method of measurement: 3MH/ Creatinine ratio in 24h urine.;Lipolysis. Timepoint: 14 days after intervention. Method of measurement: free glycerol in serum.;Dysbiosis status and luminal integrity. Timepoint: 14 days after intervention. Method of measurement: blood Endotoxin levels.
- Secondary Outcome Measures
Name Time Method Infectious complications incidence. Timepoint: daily. Method of measurement: incidence.;Ventilator- dependent days. Timepoint: 14 days after intervention. Method of measurement: number of days.;Length of ICU stay. Timepoint: 14 days after intervention. Method of measurement: number of days.;Length of hospital stay. Timepoint: 14 days after intervention. Method of measurement: number of days.;28- Day mortality. Timepoint: 28 days after intervention. Method of measurement: mortality incidence in 28 days.