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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy. What is the Relationship With Gut Microbiota?

Conditions
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Malnutrition, Pressure Ulcer

Intervention / Treatment
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* Dietary Supplement: symbiotic
* Dietary Supplement: zinc and arginine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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 | Dietary Supplement: symbiotic<br>* Feed supplementation<br>Dietary Supplement: zinc and arginine<br>* Feed supplementation<br>|
| Active Comparator: Control group<br>Control group will be administered only an enteral nutrition formula rich in zinc and arginine | Dietary Supplement: zinc and arginine<br>* Feed supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Transforming Growth Factor β (TGF-β1), Epidermal Growth Factor (EGF) and Vascular Endothelial Growth Factor (VEGF) | 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. | 90 days after the fist time point (baseline assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring modification of gut microbiota through DNA extraction and quantification | 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. | 45 days after the fist time point (baseline assessment) and 90 days after the fist time point (baseline assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, Iatrogenic malnutrition, pressure ulcer