Malnutrition, Pressure Ulcer
Conditions
Keywords
gut microbiota, Iatrogenic malnutrition, pressure ulcer
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.
Interventions
DIETARY_SUPPLEMENTsymbiotic
Feed supplementation
DIETARY_SUPPLEMENTzinc and arginine
Feed supplementation
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Transforming Growth Factor β (TGF-β1), Epidermal Growth Factor (EGF) and Vascular Endothelial Growth Factor (VEGF) | 90 days after the fist time point (baseline assessment) | Human EGF, human VEGF/human TGF-β1 will be measured on aliquots (20 μl) of plasma using Quantikine® ELISA Human Immunoassay (R&D System, Abingdon, UK), following the manufacturer's protocol. The quantitative sandwich enzyme immunoassay technique will be used. A monoclonal antibody specific for human EGF/human VEGF, is pre-coated onto a microplate. For TGF -β1 assay latent TGF-β1 must be activated before test, following a procedure of acidification and then neutralization to pH 7.2-7.6. Standards and samples are pipetted into the wells and EGF or VEGF present is bound by the immobilized antibody. After washing away unbound substances, an enzyme-linked polyclonal antibody specific for human EGF/human VEGF is added to the wells. After removing any unbound antibody-enzyme reagent, a substrate solution is added and colour develops in proportion to the amount of EGF bound. Colour development is stopped, and colour intensity measured. Tests will be performed in triplicates for each sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring modification of gut microbiota through DNA extraction and quantification | 45 days after the fist time point (baseline assessment) and 90 days after the fist time point (baseline assessment) | Total DNA will be extracted in triplicate from all the fecal samples by following the QIAamp DNA Stool Mini Kit instructions (Qiagen) and quantified with a Qubit® 2.0 fluorometer (Invitrogen, USA). Molecular weight and fragment length of DNA will be checked on 1.5 % agarose gel; the yield will be calculated as µg DNA/g feces. Quantitative PCR (qPCR) assays will be conducted using the specific primers rpoB1, rpoB1o and rpoB2 that generate amplicons of 250-bp, on 10 ng DNA templates for all the samples. Amplification will be carried out and three simultaneous replicates will be carried out for each of analyzed sample. |
Countries
Italy
Contacts
Primary ContactChiara Francesca Gheri, Dr.
Backup ContactMaria Luisa Eliana Luisi, Dr.
Outcome results
None listed