Impact of Immunonutrition on the Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Impact of Immunonutrition on the Patients With Cystic Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02048592
• Other study ID #: FN Motol-project 6008
• Secondary ID: EK-942/13
• Status: Recruiting
• Phase: Phase 4
• First received: December 16, 2013
• Last updated: January 27, 2014
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: University Hospital, Motol
• Contact: Ondrej Hloch, MD
• Phone: +420224434098
• Email: o.hloch[@]gmail.com
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objectives:

To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis

1. Safety of immunonutrition

2. The effect of immunonutrition on parameters of oxidative stress

3. The effect of immunonutrition on the inflammatory parameters

4. The effect of immunonutrition on nutrition status

Hypothesis

The high oxidative stress is present in patients with cystic fibrosis. Immunonutrition has been shown to positively modulate oxidative stress in the different clinical setting however it has not yet been evaluated inpatients with cystic fibrosis who frequently need some support by means of enteral nutrition. We anticipate that the substitution of routine enteral nutrition by immunonutrition will result in improving of oxidative stress parameters.

Description:

Method Crossover open study will take 16 weeks. The patients eligible for the study according to inclusion and exclusion criteria are going to be divided into 2 groups after signing the informed consent. In both groups their nutrition status, humoral and cellular immunity, respiratory system function and parameters of oxidative stress will be evaluated before entering the intervention.

Afterwards the patients are going to be divided into one group who will receive nutrition support using immunonutrition for the next 8 weeks while the second one will continue with their nutrition support using routine sipping support with no immunonutrition. According to our hypothesis oxidative stress parameters will improve in the group of patients on immunonutrition comparing to the other group. Afterwards the patients will change their nutrition support for another 8 weeks. The patients who took immunonutrition in the first half of study will switch back to routine sipping support and contrary the patients who were in the first part of study on routine sipping will take immunonutrition. After the end of this period of study we expect the return of oxidative stress parameters to the baseline values in the group of patients who took immunonutrition in the first half of study but who were returned to routine nutrition support and contrary the improvement of oxidative stress parameters in the patients who started to take immunonutrition in the second half of study.

The total energy support will be identical in both periods for each individual patient. After the first 8 weeks and after the completion of study the same examination are going to be evaluate as it was on the entrance to study.

Statistical analysis: means, SD, t-test, chi square test, Mann Whitney test, linear correlation and multilinear analysis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Cystic fibrosis

• adult, elder 18 years

• enteral nutrition at least for the last 12 monthes

Exclusion Criteria:

• patient waiting for lung transplant

• patients with another life limiting disease-e.g. cancers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Malnutrition
• Oxidative Stress

Intervention

Dietary Supplement:
• Impact-Nutridrink
IMPACT (immunonutrition) will be given in the first 8 weeks. Afterwards the patients will be returned to their previous nutrition support |(Nutridrink) for another 8 weeks.
• Nutridrink-Impact
In this group of patients - the study starts with period of 8 weeks with no change of previous nutrition support (Nutridrink). After 8 weeks the laboratory results will be examined ant the patients will switch to immunonutrition (Impact) for another 8 weeks. After the laboratory examination including oxidative stress parameters will be evaluated.

Locations

Country	Name	City	State
Czech Republic	Faculty hospital Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	to evaluate the change of nutrition parameters in patients with cysic fibrosis induced by the application of immunonutrition		16 weeks	Yes
Other	to evaluate the change of respiratory function in patients with cystic fibrosis induced by immunonutrition		16 weeks	Yes
Primary	to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition	Oxidative stress and parameters of antioxidant activity will be evaluated when the nutrition support is provided with classic sipping (Nutridrink-Nutricia) or by immunonutrition (Impact-Nestle)	16 weeks	Yes
Secondary	to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition		16 weeks	Yes