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

Not Applicable

• Conditions: Pressure Ulcer; Malnutrition
• Interventions: Dietary Supplement: zinc and arginine; Dietary Supplement: symbiotic

• Registration Number: NCT03627910
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Study Timeline

• Study Start: 2017-06-11
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-09
• Primary Completion: 2021-06-30
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	zinc and arginine	Control group will be administered only an enteral nutrition formula rich in zinc and arginine
Treatment group	zinc and arginine	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 group	symbiotic	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi; 🇮🇹 Firenze, Italy