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

NCT03627910 | Unknown

• 1 other identifier: ulcere1_FDG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Pressure Ulcer

Keywords

gut microbiota; Iatrogenic malnutrition; pressure ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Treatment group

EXPERIMENTAL

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; Dietary Supplement: zinc and arginine

Control group

ACTIVE COMPARATOR

Control group will be administered only an enteral nutrition formula rich in zinc and arginine

Dietary Supplement: zinc and arginine

Interventions

symbiotic DIETARY_SUPPLEMENT

Feed supplementation

Treatment group

zinc and arginine DIETARY_SUPPLEMENT

Feed supplementation

Control group; Treatment group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with enteral nutrition therapy
• Presence of pressure ulcers
• Previous antibiotic therapy

You may not qualify if:

• nutrition per os
• absence of pressure ulcers
• absence of previous antibiotic therapy

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi

Florence, 50143, Italy

RECRUITING

Related Publications (10)

• Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.

  PMID: 32887946 BACKGROUND

• Munoz N, Posthauer ME, Cereda E, Schols JMGA, Haesler E. The Role of Nutrition for Pressure Injury Prevention and Healing: The 2019 International Clinical Practice Guideline Recommendations. Adv Skin Wound Care. 2020 Mar;33(3):123-136. doi: 10.1097/01.ASW.0000653144.90739.ad.

  PMID: 32058438 BACKGROUND

• Luisi MLE, Lucarini L, Biffi B, Rafanelli E, Pietramellara G, Durante M, Vidali S, Provensi G, Madiai S, Gheri CF, Masini E, Ceccherini MT. Effect of Mediterranean Diet Enriched in High Quality Extra Virgin Olive Oil on Oxidative Stress, Inflammation and Gut Microbiota in Obese and Normal Weight Adult Subjects. Front Pharmacol. 2019 Nov 15;10:1366. doi: 10.3389/fphar.2019.01366. eCollection 2019.

  PMID: 31803056 BACKGROUND

• Cereda E, Neyens JCL, Caccialanza R, Rondanelli M, Schols JMGA. Efficacy of a Disease-Specific Nutritional Support for Pressure Ulcer Healing: A Systematic Review and Meta-Analysis. J Nutr Health Aging. 2017;21(6):655-661. doi: 10.1007/s12603-016-0822-y.

  PMID: 28537329 BACKGROUND

• Lynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. No abstract available.

  PMID: 27974040 BACKGROUND

• Valentini L, Pinto A, Bourdel-Marchasson I, Ostan R, Brigidi P, Turroni S, Hrelia S, Hrelia P, Bereswill S, Fischer A, Leoncini E, Malaguti M, Blanc-Bisson C, Durrieu J, Spazzafumo L, Buccolini F, Pryen F, Donini LM, Franceschi C, Lochs H. Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people. Clin Nutr. 2015 Aug;34(4):593-602. doi: 10.1016/j.clnu.2014.09.023. Epub 2014 Oct 8.

  PMID: 25453395 BACKGROUND

• Ammons MC, Morrissey K, Tripet BP, Van Leuven JT, Han A, Lazarus GS, Zenilman JM, Stewart PS, James GA, Copie V. Biochemical association of metabolic profile and microbiome in chronic pressure ulcer wounds. PLoS One. 2015 May 15;10(5):e0126735. doi: 10.1371/journal.pone.0126735. eCollection 2015.

  PMID: 25978400 BACKGROUND

• Wang X, Dong Y, Han X, Qi XQ, Huang CG, Hou LJ. Nutritional support for patients sustaining traumatic brain injury: a systematic review and meta-analysis of prospective studies. PLoS One. 2013;8(3):e58838. doi: 10.1371/journal.pone.0058838. Epub 2013 Mar 19.

  PMID: 23527035 BACKGROUND

• Teno JM, Gozalo P, Mitchell SL, Kuo S, Fulton AT, Mor V. Feeding tubes and the prevention or healing of pressure ulcers. Arch Intern Med. 2012 May 14;172(9):697-701. doi: 10.1001/archinternmed.2012.1200.

  PMID: 22782196 BACKGROUND

• Ohura T, Nakajo T, Okada S, Omura K, Adachi K. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial). Wound Repair Regen. 2011 May-Jun;19(3):330-6. doi: 10.1111/j.1524-475X.2011.00691.x.

  PMID: 21539650 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Pressure Ulcer

Interventions

Zinc; Arginine

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Maria Luisa Eliana Luisi, MD

  Don Gnocchi Foundation, Italy

  STUDY CHAIR

Central Study Contacts

Chiara Francesca Gheri, Dr.

CONTACT

00393281512053; cgheri@dongnocchi.it

Maria Luisa Eliana Luisi, Dr.

CONTACT

3356305688; mluisi@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 14, 2018
• Study Start: June 11, 2017
• Primary Completion: June 30, 2021
• Study Completion: January 31, 2022
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)