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Impact of Immunonutrition on the Patients With Cystic Fibrosis

NCT02048592 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-01-29

No results posted yet for this study

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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Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospital, Motol

    lead OTHER

Principal Investigators

  • Ondrej Hloch, MD · Faculty hospital Motol

  • Jiri Charvat, MD · Faculty hospital Motol

  • Milan Kvapil, MD · Faculty hospital Motol

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Czechia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048592 on ClinicalTrials.gov