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Clinical Trial Summary

Participants will be randomly assigned to the experimental group where they will be given enteral nutrition formula rich in zinc and arginine plus a symbiotic (Probinul- Ca.Di.GROUP S.r.l.) once a day for 90 days or the control group where they will receive only the enteral nutrition formula rich in zinc and arginine.


Clinical Trial Description

Participants belonging to both experimental and control group will be evaluated at admission (T0), 45 days after admission (T45) and at the end of the study (T90, 90 days after admission). At each time point patients' nutritional status will be determined and the following biochemical parameters will be investigated: lymphocyte count, total proteins, protidogram, prealbumin, transferrin, vascular endothelial growth factor (VEGF), Platelet-derived growth factor (PDGF), beta transforming growth factor (TGF-beta). Analysis of fecal DNA will be also performed to characterize the gut microbiota. In addition, at the baseline and at T45 participants will be administered the Braden scale for predicting pressure sore risk. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03627910
Study type Interventional
Source Fondazione Don Carlo Gnocchi Onlus
Contact Chiara Francesca Gheri, Dr.
Phone 00393281512053
Email cgheri@dongnocchi.it
Status Recruiting
Phase N/A
Start date June 11, 2017
Completion date January 31, 2022

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