Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota

  • End date
    Jan 31, 2022
  • participants needed
  • sponsor
    Fondazione Don Carlo Gnocchi Onlus
Updated on 15 February 2021
growth factor
tube feeding
vascular endothelial growth factor
nutritional supplement
nutritional support
pressure ulcers


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.


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.

Condition Decubitus Ulcer, Malnutrition, Malnutrition, Bed Sores (Decubitus Ulcers), Pressure Ulcers, Pressure Ulcer, deficiency, malnourished, undernutrition, nutritional deficiency, nutritional deficiencies, undernourished, poor nutrition, pressure sores, decubitus, bedsore
Treatment symbiotic, zinc and arginine
Clinical Study IdentifierNCT03627910
SponsorFondazione Don Carlo Gnocchi Onlus
Last Modified on15 February 2021


Yes No Not Sure

Inclusion Criteria

Patients with enteral nutrition therapy
Presence of pressure ulcers
Previous antibiotic therapy

Exclusion Criteria

nutrition per os
absence of pressure ulcers
absence of previous antibiotic therapy
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