Neurological DiseasesPhase 4NCT00560157
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
A Phase 4 study testing Crucial (enteral tube feeding) in people with Neurological Diseases and Pneumopathy, run by Société des Produits Nestlé (SPN) at 2 sites in France.
Trial summary
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Neurological Diseases, Pneumopathy, Major Abdominal Surgery
- What is being tested?
- Crucial (enteral tube feeding)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2002to Mar 2006
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18<age<89, ASA score<4 , SAPS II score>10
- requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
- ICU patients hospitalized for:
- neurologic affections
- pneumopathy
- major abdominal surgery or serious acute pancreatitis
- written informed consent
Who cannot join
- pregnancy or breast feeding
- immunosuppressive therapy
- radiotherapy or chemotherapy in the last six month
- uncontrolled septic choc
- auto-immune disease
- hepatic,renal or digestive insufficiency
Show all 11Show fewer
- hyperlipidemia
- diabetes mellitus type 1
- digestive malabsorption
- life threatening situation
- treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital A. BECLERE
Clamart, 92141
Hopital Saint Antoine
Paris, 75571
About this study
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients
- Being tested
- Crucial (enteral tube feeding)
- Keywords
- ICU patients
- Medical subject headings
- Lung Diseases, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crucial (enteral tube feeding)Dietary supplement
Evaluation of new enteral product, Crucial, in ICU patients
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Sondalis HP Receives: Dietary Supplement: Crucial (enteral tube feeding) |
| II | Experimental | Crucial Receives: Dietary Supplement: Crucial (enteral tube feeding) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of Glutamine after 90 min of enteral product administration
Measured: J5
Secondary outcomes (2)
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
Measured: J1, J5, J8
Tolerance
Measured: Daily until J8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startDec 2002
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DiseasesStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luc CYNOBER, PhD, Study chair, University PARIS V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560157
- Sponsor's protocol ID
- NCNF 0401
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2007
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients
- ClinicalTrials.gov ID
- NCT00560157
- Acronym / sponsor ID
- NCNF 0401
- Keywords
- ICU patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 19 Nov 2007 (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.
Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Dietary Supplement: Crucial (enteral tube feeding)Sondalis HP |
| II | Experimental | Dietary Supplement: Crucial (enteral tube feeding)Crucial |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18<age<89, ASA score<4 , SAPS II score>10
- requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
- ICU patients hospitalized for:
- neurologic affections
- pneumopathy
Key exclusion criteria (11 listed)
- pregnancy or breast feeding
- immunosuppressive therapy
- radiotherapy or chemotherapy in the last six month
- uncontrolled septic choc
- auto-immune disease
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 |
|---|---|---|
| Crucial (enteral tube feeding)Evaluation of new enteral product, Crucial, in ICU patients | Dietary supplement | I, II |
Primary outcome
Variation of Glutamine after 90 min of enteral product administration
Time frame: J5
2 secondary outcomes
Nutritional parameters, immunologic parameters, functionality renal, Biological marker of oxidative stress
Time frame: J1, J5, J8
Tolerance
Time frame: Daily until J8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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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.
Luc CYNOBER, PhD study chair
University PARIS V
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Crucial (enteral tube feeding) in people with Neurological Diseases and Pneumopathy, run by Société des Produits Nestlé (SPN) at 2 sites in France.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of Glutamine after 90 min of enteral product administration (time frame: J5). 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 19 Nov 2013.