Effects of Immunonutrition in Patients With Pneumonia

Pneumonia Clinical Trial

Official title:

Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249050
• Other study ID #: H-19088763
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: April 2020
• Source: University of Copenhagen
• Contact: Jens R Andersen, Assoc. Prof.
• Phone: 004523346654
• Email: jra[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project is a randomized controlled trial taking place in the North Zealand hospital in the city Hilleroed, Denmark.

The aim is to investigate the potential beneficial effects of immunonutrition containing fish oil, arginine and RNA, on the acute immune response in patients with pneumonia.

Description:

Immunonutrition has a well-documented beneficial effect on surgical patients by strengthening the immune system and reducing the following: inflammation, the number of infections as well as hospitalization time. A study in operated patients demonstrated the benefit of immunonutrition by reducing unwanted inflammation, measured by the pro-inflammatory signalling protein, interleukin-6. The same study saw a smaller decrease in immune function (measured as the level of phagocytosis) in the group receiving immunonutrition than in the control group. This project will investigate whether similar effects can be detected in patients with pneumonia.

The project is being carried out in a collaboration between the University of Copenhagen, The main hospital of Copenhagen (Rigshospitalet) and North Zealand Hospital. The project is a randomized clinical intervention study, which spans 10 days. Participants are allocated to the intervention group or the control group. The project is being carried out at the North Zealand hospital, at the Department of Pulmonary- and Infectious Diseases.

The intervention group receives the department's standard treatment (Standard Of Care) + immunonutrition, while the control group receives the hospital department's standard treatment (Standard Of Care). On a daily basis, the patient's clinical condition and the activity of the immune system is measured for the purpose of determine whether there is an effect of immunonutrition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 15, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Authorized individuals diagnosed with pneumonia who speak and write in danish

Exclusion Criteria:

• individuals with Immunodeficiency

• individuals with another primary diagnose

• individuals with an allergy against product ingredients

• individuals with dementia

• individuals with dysphagia

• individuals with cancer in treatment

• individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment

Related Conditions & MeSH terms

• Lung Infection
• Malnutrition
• Muscle Loss
• Pneumonia
• Pulmonary Disease

Intervention

Dietary Supplement:
• Oral Impact powder
Oral nutritional supplement containing fish oil, arginine and RNA

Locations

Country	Name	City	State
Denmark	Department of Lung Medicine and Infectious Diseases	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. — View Citation

Marimuthu K, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of the effect of combinations of immune modulating nutrients on outcome in patients undergoing major open gastrointestinal surgery. Ann Surg. 2012 Jun;255(6):1060-8. doi: 10.1097/SLA.0b013e3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6	Measure of the acute immune response	daily measure from first day of inclusion until discharge (maximum 10 days)
Secondary	Length of stay	Measure of hospitalized days	From admittance to discharge (maximum 10 days)
Secondary	Hand grip strength	Measure of the mobilization of strength	Daily from admittance to discharge (maximum 10 days)