Impact of Immunonutrition on the Patients With Cystic Fibrosis

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.

,

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Cystic Fibrosis; Oxidative Stress
• Intervention / Treatment: Dietary supplement: Impact-Nutridrink; Dietary supplement: Nutridrink-Impact

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ondrej Hloch, MD; Phone Number: +420224434098; Email: o.hloch@gmail.com
• Study Contact Backup: Name: Jiri Charvat, MD; Phone Number: +420224434051; Email: jiri.charvat@fnmotol.cz

Study Locations

• Czech Republic
  • Prague, Czech Republic, 15006
    • Recruiting
    • Faculty Hospital Motol
    • Contact: Libor Fila, MD; Phone Number: +420224436630; Email: libor.fila@fnmotol.cz
    • Principal Investigator: Ondrej Hloch, MD
    • Sub-Investigator: Libor Fila, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Impact-Nutridrink; The first arm will be given immunonutrition -Impact- for 8 weeks, afterwards the patients will return to their previous nutrition support for another 8 weeks. We expect the improvement of oxidative stress parameters after 8 weeks of immunonutriton and return to baseline values when immunonutrition is stopped	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.; Other Names: Impact is brand name of oral nutrition produced by Nestle-Switzerland. It improves immune system; Nutridrink is brand name of oral nutrition produced by company Nutricia (Denmark) with no effect on immune system.
Active Comparator: Nutridrink-Impact; The second group will be given their previous nutrition support (Nutridrink) for 8 weeks, afterwards the patients will be switched to immunonutrition- Impact- for another 8 weeks. In this group of patients we do not expect any change of oxidative stress parameters after the first 8 weeks. The improvement is expected at the end of the second half of study.	Dietary supplement: 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.; Other Names: Impact- brand name for immunonutrition - company Nestle Switzerland; Nutridrink- nutrition of company Nutriticia (Denmark)- with no immune response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition	16 weeks

Other Outcome Measures

Outcome Measure	Time Frame
to evaluate the change of nutrition parameters in patients with cysic fibrosis induced by the application of immunonutrition	16 weeks
to evaluate the change of respiratory function in patients with cystic fibrosis induced by immunonutrition	16 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Principal Investigator: Ondrej Hloch, MD, Faculty Hospital Motol; Study Chair: Jiri Charvat, MD, Faculty Hospital Motol; Study Director: Milan Kvapil, MD, Faculty Hospital Motol

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: cystic fibrosis, immunonutrition, oxidative stress
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Malnutrition
• Other Study ID Numbers: FN Motol-project 6008; EK-942/13 (Other Identifier: Faculty hospital Prague Motol)