Clinical trial NCT03627910: Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota
Official title: Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy. What is the Relationship With Gut Microbiota?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Pressure Ulcer
Keywords: gut microbiota
Iatrogenic malnutrition
pressure ulcer
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of Transforming Growth Factor β (TGF-β1), Epidermal Growth Factor (EGF) and Vascular Endothelial Growth Factor (VEGF)
timeFrame: 90 days after the fist time point (baseline assessment)
Secondary outcomes:
measure: Monitoring modification of gut microbiota through DNA extraction and quantification
timeFrame: 45 days after the fist time point (baseline assessment) and 90 days after the fist time point (baseline assessment)
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Fondazione Don Carlo Gnocchi
Study officials:
affiliation: Don Gnocchi Foundation, Italy
name: Maria Luisa Eliana Luisi, MD
role: STUDY_CHAIR
References:
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