Cystic FibrosisVITJUNIORNCT02128984
Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
A study testing Symbiotic Formula with DHA and antioxidants and Standard Formula in people with Cystic Fibrosis and Failure to Thrive, run by Laboratorios Ordesa at 8 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cystic Fibrosis, Failure to Thrive, Malnutrition
- What is being tested?
- Symbiotic Formula with DHA and antioxidants and Standard Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 2012to May 2015
- Phase
- Interventional
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
- Age >= 1 year.
- Stable patients
- No antibiotherapy in the last 30 days
- Inform consent signed (parent/legal representative)
Who cannot join
- Patients with allergy / intolerance to cow's milk proteins
- Metabolically unstable patient
- Patients with metabolic intolerance to carbohydrates
- Patients with severe disease in the last 30 days
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Spain7 sites
Hospital de Torrecárdenas
Almería, 04009
Hospital Puerta del Mar
Cadiz, 11009
Hospital Universitario Santa Lucía
Cartagena, Murcia, 30202
Hospital de Henares
Coslada, Madrid, 28822
Hospital Universitario La Paz
Madrid, 28046
Hospital Virgen Macarena
Seville, 41009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.
Read the detailed description
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.
- Conditions
- Cystic Fibrosis, Failure to Thrive, Malnutrition
- Being tested
- Symbiotic Formula with DHA and antioxidants, Standard Formula
- Keywords
- Malnutrition, Dietary supplement, Nutritional supplement, Symbiotic formula, DHA, Cystic Fibrosis, Failure to Thrive
- Medical subject headings
- Cystic Fibrosis, Failure to Thrive, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbiotic Formula with DHA and antioxidantsDietary supplement
Also called Vitafos Junior
6 months intervention.
Standard FormulaDietary supplement
6 months intervention.
| Study group | Role | What they receive |
|---|---|---|
| Vitafos Junior | Experimental | Symbiotic Formula with DHA and antioxidants Receives: Dietary Supplement: Symbiotic Formula with DHA and antioxidants |
| Standard Formula | Active comparator | Standard isocaloric and isonitrogenous formula. Receives: Dietary Supplement: Standard Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in inflammatory response
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
Measured: At 3rd and 6th months
Secondary outcomes (4)
Changes in nutritional status
Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.
Measured: At 3rd and 6th months
Changes in microbiota profile
Differences measured by changes in faecal microbiota composition.
Measured: At 3rd and 6th months
Changes in Interleukin levels
Differences in faecal interleukin levels. Only for cystic fibrosis patients.
Measured: At 6th month
Incidence of Infections
Episodes of infections during the study period
Measured: At 1st, 3rd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionMay 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quantum Experimental, Peruvian Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128984
- Sponsor's protocol ID
- VIT-2572-011
- Acronym
- VITJUNIOR
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2014
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
- ClinicalTrials.gov ID
- NCT02128984
- Acronym / sponsor ID
- VITJUNIOR / VIT-2572-011
- Conditions
- Cystic Fibrosis, Failure to Thrive, Malnutrition
- Keywords
- Malnutrition, Dietary supplement, Nutritional supplement, Symbiotic formula, DHA, Cystic Fibrosis, Failure to Thrive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Quantum Experimental, Peruvian Clinical Research
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 May 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 purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.
Detailed description
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitafos Junior | Experimental | Dietary Supplement: Symbiotic Formula with DHA and antioxidantsSymbiotic Formula with DHA and antioxidants |
| Standard Formula | Active comparator | Dietary Supplement: Standard FormulaStandard isocaloric and isonitrogenous formula. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
- Age >= 1 year.
- Stable patients
- No antibiotherapy in the last 30 days
- Inform consent signed (parent/legal representative)
Key exclusion criteria (4 listed)
- Patients with allergy / intolerance to cow's milk proteins
- Metabolically unstable patient
- Patients with metabolic intolerance to carbohydrates
- Patients with severe disease in the last 30 days
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 |
|---|---|---|
| Symbiotic Formula with DHA and antioxidantsAlso: Vitafos Junior6 months intervention. | Dietary supplement | Vitafos Junior |
| Standard Formula6 months intervention. | Dietary supplement | Standard Formula |
Primary outcome
Changes in inflammatory response
Time frame: At 3rd and 6th months
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
4 secondary outcomes
Changes in nutritional status
Time frame: At 3rd and 6th months
Changes in microbiota profile
Time frame: At 3rd and 6th months
Changes in Interleukin levels
Time frame: At 6th month
Incidence of Infections
Time frame: At 1st, 3rd and 6th months
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 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiotic Formula with DHA and antioxidants and Standard Formula in people with Cystic Fibrosis and Failure to Thrive, run by Laboratorios Ordesa at 8 sites in 2 countries.
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 5 inclusion and 4 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Peru. 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.
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?
Changes in inflammatory response (time frame: At 3rd and 6th months). 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 Jul 2019.