Clinical trial NCT02048592: Impact of Immunonutrition on the Patients With Cystic Fibrosis
Official title: Impact of Immunonutrition on the Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cystic Fibrosis
Malnutrition
Oxidative Stress
Keywords: cystic fibrosis, immunonutrition, oxidative stress
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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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

Eligibility criteria: 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

Primary outcomes:
measure: to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition
timeFrame: 16 weeks
Secondary outcomes:
measure: to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition
timeFrame: 16 weeks
Other outcomes:
measure: to evaluate the change of nutrition parameters in patients with cysic fibrosis induced by the application of immunonutrition
timeFrame: 16 weeks
measure: to evaluate the change of respiratory function in patients with cystic fibrosis induced by immunonutrition
timeFrame: 16 weeks
Locations:
city: Prague
country: Czech Republic
facility: Faculty hospital Motol
Study officials:
affiliation: Faculty hospital Motol
name: Ondrej Hloch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty hospital Motol
name: Jiri Charvat, MD
role: STUDY_CHAIR
affiliation: Faculty hospital Motol
name: Milan Kvapil, MD
role: STUDY_DIRECTOR
References: