Impact of Immunonutrition on the Patients With Cystic Fibrosis

University Hospital, Motol

Status and phase: Unknown; Phase 4

Conditions: Malnutrition; Oxidative Stress; Cystic Fibrosis

Treatments: Dietary Supplement: Nutridrink-Impact; Dietary Supplement: Impact-Nutridrink

Study type: Interventional

Funder types: Other

Identifiers

NCT02048592

FN Motol-project 6008

EK-942/13 (Other Identifier)

Details and patient eligibility

About

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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Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Impact-Nutridrink

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Impact-Nutridrink

Nutridrink-Impact

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutridrink-Impact