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The effects of enteral Royal jelly supplementation in critically ill patients

Phase 2
Conditions
Supportive care critically ill patient stay in intentensive care unit.
Symptoms and signs involving the digestive system and abdomen
Registration Number
IRCT2016073029127N1
Lead Sponsor
Vice chancellor for research, Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Critically ill patients aged older than 18 years and less than 65 years; at least two signs of systemic inflammatory response syndrome (body temperature above 38 C° or less than 36 C°, heart rate more than 90 min without drug interactions , respiratory rate more than 20 in minutes, WBC lees than 4000 or more than12,000 or more than 10% immature neutrophils); at least a measure organ dysfunction syndrome (oliguria acute or urine output <0.5 ml/kg/min for at least two hours despite the revival of adequate fluids, coagulation disorders)
Exclusion criteria: Pregnancy and lactation; taking dose of antifungal ,catecholamine and vasopressor Drugs; Immunocompromised patients; liver failure (changes in liver enzymes more than twice normal); renal failure (serum creatinine levels> 2); gastric acidity(pH) less than 3.5

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quantitative GUT microbiota pattern. Timepoint: Baseline,3 and 7 days after intervention. Method of measurement: Extraction and purification of DNA Microbiota of fecal samples or stomach juice by using Real-time PCR and Fast Start Univesal SYBR green master with Light cycler ® 96 and draw Amplification curve.;Serum Endocan Level. Timepoint: Baseline and seventh day after intervention. Method of measurement: Serum endocan levels is measured using an endocan enzyme-linked immunosorbent assay (ELISA) kit.
Secondary Outcome Measures
NameTimeMethod
Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Scores. Timepoint: Baseline, 3 and 7 days after intervention. Method of measurement: Standard questionnaire.
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