Impact of Immunonutrition on the Patients With Cystic Fibrosis

Study Overview
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Brief Summary
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The primary objectives: To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis Safety of immunonutrition The effect of immunonutrition on parameters of oxidative stress The effect of immunonutrition on the inflammatory parameters 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. ,

Detailed Description
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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

Official Title
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Impact of Immunonutrition on the Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis, Malnutrition, Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: Impact-Nutridrink
* Dietary Supplement: Nutridrink-Impact


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Impact-Nutridrink<br>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<br>* 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.<br>* Other names: Nutridrink is brand name of oral nutrition produced by company Nutricia (Denmark) with no effect on immune system.;|
| Active Comparator: Nutridrink-Impact<br>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<br>* 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.<br>* Other names: Nutridrink- nutrition of company Nutriticia (Denmark)- with no immune response;|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, immunonutrition, oxidative stress