Impact of Immunonutrition on the Patients With Cystic Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital, Motol
Sponsor:
Information provided by (Responsible Party):
Ondrej Hloch MD, University Hospital, Motol
ClinicalTrials.gov Identifier:
NCT02048592
First received: December 16, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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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Condition Intervention Phase
Cystic Fibrosis
Malnutrition
Oxidative Stress
Dietary Supplement: Impact-Nutridrink
Dietary Supplement: Nutridrink-Impact
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Immunonutrition on the Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University Hospital, Motol:

Primary Outcome Measures:
  • to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • to evaluate the change of nutrition parameters in patients with cysic fibrosis induced by the application of immunonutrition [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • to evaluate the change of respiratory function in patients with cystic fibrosis induced by immunonutrition [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Impact is brand name of oral nutrition produced by Nestle-Switzerland. It improves immune system
  • Nutridrink is brand name of oral nutrition produced by company Nutricia (Denmark) with no effect on immune system.
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.
Other Names:
  • Impact- brand name for immunonutrition - company Nestle Switzerland
  • Nutridrink- nutrition of company Nutriticia (Denmark)- with no immune response

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048592

Contacts
Contact: Ondrej Hloch, MD +420224434098 o.hloch@gmail.com
Contact: Jiri Charvat, MD +420224434051 jiri.charvat@fnmotol.cz

Locations
Czech Republic
Faculty hospital Motol Recruiting
Prague, Czech Republic, 15006
Contact: Libor Fila, MD    +420224436630    libor.fila@fnmotol.cz   
Principal Investigator: Ondrej Hloch, MD         
Sub-Investigator: Libor Fila, MD         
Sponsors and Collaborators
University Hospital, Motol
Investigators
Principal Investigator: Ondrej Hloch, MD Faculty hospital Motol
Study Chair: Jiri Charvat, MD Faculty hospital Motol
Study Director: Milan Kvapil, MD Faculty hospital Motol
  More Information

No publications provided

Responsible Party: Ondrej Hloch MD, Dpt. of of Internal Medicine, 2nd Medical School of Charles Universty and University Hospital Moto, University Hospital, Motol
ClinicalTrials.gov Identifier: NCT02048592     History of Changes
Other Study ID Numbers: FN Motol-project 6008, EK-942/13
Study First Received: December 16, 2013
Last Updated: January 27, 2014
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital, Motol:
cystic fibrosis, immunonutrition, oxidative stress

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Malnutrition
Nutrition Disorders
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014