Cystic FibrosisPhase 4NCT02048592
Impact of Immunonutrition on the Patients With Cystic Fibrosis
A Phase 4 study testing Impact-Nutridrink and Nutridrink-Impact in people with Cystic Fibrosis and Malnutrition, run by University Hospital, Motol at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Cystic Fibrosis, Malnutrition, Oxidative Stress
- What is being tested?
- Impact-Nutridrink and Nutridrink-Impact
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cystic fibrosis
- adult, elder 18 years
- enteral nutrition at least for the last 12 monthes
Who cannot join
- patient waiting for lung transplant
- patients with another life limiting disease-e.g. cancers
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Faculty hospital Motol
Prague, 15006
Libor Fila, MD, +420224436630, libor.fila@fnmotol.cz
Ondrej Hloch, MD
About this study
The primary objectives:
To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis
Read more
- Safety of immunonutrition
- The effect of immunonutrition on parameters of oxidative stress
- The effect of immunonutrition on the inflammatory parameters
- 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.
,
Read the 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
- Conditions
- Cystic Fibrosis, Malnutrition, Oxidative Stress
- Being tested
- Impact-Nutridrink, Nutridrink-Impact
- Keywords
- cystic fibrosis, immunonutrition, oxidative stress
- Medical subject headings
- Cystic Fibrosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact-NutridrinkDietary supplement
Also called 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.
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.
Nutridrink-ImpactDietary supplement
Also called Impact- brand name for immunonutrition - company Nestle Switzerland, Nutridrink- nutrition of company Nutriticia (Denmark)- with no immune response
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.
| Study group | Role | What they receive |
|---|---|---|
| Impact-Nutridrink | Active comparator | 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 Receives: Dietary Supplement: Impact-Nutridrink |
| Nutridrink-Impact | Active comparator | 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. Receives: Dietary Supplement: Nutridrink-Impact |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition
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)
Measured: 16 weeks
Secondary outcomes (1)
to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ondrej Hloch MD, University Hospital, Motol
- Investigators
- Ondrej Hloch, MD, Principal investigator, Faculty hospital MotolJiri Charvat, MD, Study chair, Faculty hospital MotolMilan Kvapil, MD, Study director, Faculty hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048592
- Sponsor's protocol ID
- FN Motol-project 6008
- Other IDs
- EK-942/13
- Status last verified
- Jan 2014
- First submitted
- 16 Dec 2013
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunonutrition on the Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02048592
- Acronym / sponsor ID
- FN Motol-project 6008
- Conditions
- Cystic Fibrosis, Malnutrition, Oxidative Stress
- Keywords
- cystic fibrosis, immunonutrition, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives:
To evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis
- Safety of immunonutrition
- The effect of immunonutrition on parameters of oxidative stress
- The effect of immunonutrition on the inflammatory parameters
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impact-Nutridrink | Active comparator | Dietary Supplement: Impact-NutridrinkThe 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 |
| Nutridrink-Impact | Active comparator | Dietary Supplement: Nutridrink-ImpactThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cystic fibrosis
- adult, elder 18 years
- enteral nutrition at least for the last 12 monthes
Key exclusion criteria (2 listed)
- patient waiting for lung transplant
- patients with another life limiting disease-e.g. cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact-NutridrinkAlso: 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.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 | Impact-Nutridrink |
| Nutridrink-ImpactAlso: Impact- brand name for immunonutrition - company Nestle Switzerland, Nutridrink- nutrition of company Nutriticia (Denmark)- with no immune responseIn 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. | Dietary supplement | Nutridrink-Impact |
Primary outcome
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)
1 secondary outcome
to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondrej Hloch, MD principal investigator
Faculty hospital Motol
Jiri Charvat, MD study chair
Faculty hospital Motol
Milan Kvapil, MD study director
Faculty hospital Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Impact-Nutridrink and Nutridrink-Impact in people with Cystic Fibrosis and Malnutrition, run by University Hospital, Motol at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ondrej Hloch, MD (+420224434098, o.hloch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.