Ignite Creation Date:
2024-05-06 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03627910
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2018-08-01
Brief Title:
Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy What is the Relationship With Gut Microbiota
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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- CaDiGROUP Srl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None