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| ID | Type | Description | Link |
|---|---|---|---|
| EK-942/13 | Other Identifier | Faculty hospital Prague Motol |
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The primary objectives:
To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis
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.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impact-Nutridrink | Active Comparator | 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 |
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| Nutridrink-Impact | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impact-Nutridrink | Dietary Supplement | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition | 16 weeks |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ondrej Hloch, MD | Contact | +420224434098 | o.hloch@gmail.com | |
| Jiri Charvat, MD | Contact | +420224434051 | jiri.charvat@fnmotol.cz |
| Name | Affiliation | Role |
|---|---|---|
| Ondrej Hloch, MD | Faculty hospital Motol | Principal Investigator |
| Jiri Charvat, MD | Faculty hospital Motol | Study Chair |
| Milan Kvapil, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty hospital Motol | Recruiting | Prague | 15006 | Czechia |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Nutridrink-Impact | Dietary Supplement | 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. |
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| Faculty hospital Motol |
| Study Director |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |