Impact of Immunonutrition on the Patients With Cystic Fibrosis
NCT ID: NCT02048592
Last Updated: 2014-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2013-09-30
2014-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* adult, elder 18 years
* enteral nutrition at least for the last 12 monthes
Exclusion Criteria
* patients with another life limiting disease-e.g. cancers
18 Years
40 Years
ALL
No
Sponsors
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University Hospital, Motol
OTHER
Responsible Party
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Ondrej Hloch MD
Dpt. of of Internal Medicine, 2nd Medical School of Charles Universty and University Hospital Moto
Principal Investigators
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Ondrej Hloch, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty hospital Motol
Jiri Charvat, MD
Role: STUDY_CHAIR
Faculty hospital Motol
Milan Kvapil, MD
Role: STUDY_DIRECTOR
Faculty hospital Motol
Locations
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Faculty hospital Motol
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EK-942/13
Identifier Type: OTHER
Identifier Source: secondary_id
FN Motol-project 6008
Identifier Type: -
Identifier Source: org_study_id
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