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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2022
  • participants needed
    30
  • sponsor
    Fondazione Don Carlo Gnocchi Onlus
Updated on 15 February 2021
antibiotics
prealbumin
vegf
growth factor
microbiota
tube feeding
sore
zinc
vascular endothelial growth factor
nutritional supplement
transferrin
nutritional support
tgf-beta
pressure ulcers

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.

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.

Details
Condition Decubitus Ulcer, Malnutrition, Malnutrition, Bed Sores (Decubitus Ulcers), Pressure Ulcers, Pressure Ulcer, deficiency, malnourished, undernutrition, nutritional deficiency, nutritional deficiencies, undernourished, poor nutrition, pressure sores, decubitus, bedsore
Treatment symbiotic, zinc and arginine
Clinical Study IdentifierNCT03627910
SponsorFondazione Don Carlo Gnocchi Onlus
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note