Impact of Immunonutrition on the Patients With Cystic Fibrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02048592|
Recruitment Status : Unknown
Verified January 2014 by Ondrej Hloch MD, University Hospital, Motol.
Recruitment status was: Recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Malnutrition Oxidative Stress||Dietary Supplement: Impact-Nutridrink Dietary Supplement: Nutridrink-Impact||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Immunonutrition on the Patients With Cystic Fibrosis|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2014|
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.
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.
- to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition [ Time Frame: 16 weeks ]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)
- to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition [ Time Frame: 16 weeks ]
- to evaluate the change of nutrition parameters in patients with cysic fibrosis induced by the application of immunonutrition [ Time Frame: 16 weeks ]
- to evaluate the change of respiratory function in patients with cystic fibrosis induced by immunonutrition [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048592
|Contact: Ondrej Hloch, MDemail@example.com|
|Contact: Jiri Charvat, MDfirstname.lastname@example.org|
|Faculty hospital Motol||Recruiting|
|Prague, Czech Republic, 15006|
|Contact: Libor Fila, MD +420224436630 email@example.com|
|Principal Investigator: Ondrej Hloch, MD|
|Sub-Investigator: Libor Fila, MD|
|Principal Investigator:||Ondrej Hloch, MD||Faculty hospital Motol|
|Study Chair:||Jiri Charvat, MD||Faculty hospital Motol|
|Study Director:||Milan Kvapil, MD||Faculty hospital Motol|