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Impact of Immunonutrition on the Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02048592
Recruitment Status : Unknown
Verified January 2014 by Ondrej Hloch MD, University Hospital, Motol.
Recruitment status was:  Recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Ondrej Hloch MD, University Hospital, Motol

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE January 29, 2014
Last Update Posted Date January 29, 2014
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition [ Time Frame: 16 weeks ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 27, 2014)
  • to evaluate the change of nutrition parameters in patients with cysic fibrosis induced by the application of immunonutrition [ Time Frame: 16 weeks ]
  • to evaluate the change of respiratory function in patients with cystic fibrosis induced by immunonutrition [ Time Frame: 16 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of Immunonutrition on the Patients With Cystic Fibrosis
Official Title  ICMJE Impact of Immunonutrition on the Patients With Cystic Fibrosis
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.

,

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cystic Fibrosis
  • Malnutrition
  • Oxidative Stress
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Impact-Nutridrink
  • 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.
    Intervention: Dietary Supplement: Nutridrink-Impact
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 27, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02048592
Other Study ID Numbers  ICMJE FN Motol-project 6008
EK-942/13 ( Other Identifier: Faculty hospital Prague Motol )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ondrej Hloch MD, University Hospital, Motol
Study Sponsor  ICMJE University Hospital, Motol
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ondrej Hloch, MD Faculty hospital Motol
Study Chair: Jiri Charvat, MD Faculty hospital Motol
Study Director: Milan Kvapil, MD Faculty hospital Motol
PRS Account University Hospital, Motol
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP