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

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

Conditions: Malnutrition; Pressure Ulcer

Treatments: Dietary Supplement: zinc and arginine; Dietary Supplement: symbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03627910

ulcere1_FDG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Treatment group

Experimental group

Description:

Participants assigned to the treatment group will be administered a commercial symbiotic (Probinul Ca.Di.GROUP S.r.l.) for the entire duration of the study (90 days) plus an enteral nutrition formula rich in zinc and arginine

Treatment:

Dietary Supplement: symbiotic

Dietary Supplement: zinc and arginine

Control group

Active Comparator group

Description:

Control group will be administered only an enteral nutrition formula rich in zinc and arginine

Treatment:

Dietary Supplement: zinc and arginine