Milk HypersensitivityParadiceNCT01998074
Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy
A study testing extensively hydrolyzed rice protein formula in people with Milk Hypersensitivity and Food Sensitivity, run by United Pharmaceuticals at 1 site in Belgium.
Trial summary
The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy. Read more about this study
- Who is it for?
- Ages 2 weeks to 6 months
- Conditions the study is for
- Milk Hypersensitivity, Food Sensitivity, Protein Allergy
- What is being tested?
- extensively hydrolyzed rice protein formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Start not givento Nov 2013
- 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 2 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants between 2 weeks and 6 months old
- In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month
Who cannot join
- Exclusively breast fed infants
- Preterm infants
- Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
- Infants fed an amino acid based formula
- Infants who had an anaphylactic reaction in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy
The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.
- Conditions
- Milk Hypersensitivity, Food Sensitivity, Protein Allergy
- Being tested
- extensively hydrolyzed rice protein formula
- Keywords
- Cow's Milk protein Allergy
- Medical subject headings
- Milk Hypersensitivity, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extensively hydrolyzed rice protein formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Study formula | Experimental | Not described Receives: Dietary Supplement: extensively hydrolyzed rice protein formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Measured: at 4 weeks
Secondary outcomes (5)
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Measured: at 3 months
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Measured: at 6 months
Growth (weight, height, head circumference)
Measured: 1 month
Growth (weight, height, head circumference)
Measured: 3 months
Growth (weight, height, head circumference)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Milk HypersensitivityStudies 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
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998074
- Sponsor's protocol ID
- UP2010-Paradice
- Other IDs
- BUN 143201010095
- Acronym
- Paradice
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vandenplas Y, De Greef E, Hauser B; Paradice Study Group; Paradice Study Group. An extensively hydrolysed rice protein-based formula in the management of infants with cow's milk protein allergy: preliminary results after 1 month. Arch Dis Child. 2014 Oct;99(10):933-6. doi: 10.1136/archdischild-2013-304727. Epub 2014 Jun 9.
PubMed 24914098
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT01998074
- Acronym / sponsor ID
- Paradice / UP2010-Paradice
- Conditions
- Milk Hypersensitivity, Food Sensitivity, Protein Allergy
- Keywords
- Cow's Milk protein Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Primary completion
- Nov 2013 (actual)
- First posted
- 28 Nov 2013 (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 aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study formula | Experimental | Dietary Supplement: extensively hydrolyzed rice protein formula |
Who may qualify
- Ages
- 2 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants between 2 weeks and 6 months old
- In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month
Key exclusion criteria (5 listed)
- Exclusively breast fed infants
- Preterm infants
- Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
- Infants fed an amino acid based formula
- Infants who had an anaphylactic reaction in the past
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 |
|---|---|---|
| extensively hydrolyzed rice protein formula | Dietary supplement | Study formula |
Primary outcome
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time frame: at 4 weeks
5 secondary outcomes
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time frame: at 3 months
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score
Time frame: at 6 months
Growth (weight, height, head circumference)
Time frame: 1 month
Growth (weight, height, head circumference)
Time frame: 3 months
Growth (weight, height, head circumference)
Time frame: 6 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 28 Nov 2013.
- Derived from this study: PubMed 24914098Vandenplas Y, De Greef E, Hauser B; Paradice Study Group; Paradice Study Group. An extensively hydrolysed rice protein-based formula in the management of infants with cow's milk protein allergy: preliminary results after 1 month. Arch Dis Child. 2014 Oct;99(10):933-6. doi: 10.1136/archdischild-2013-304727. Epub 2014 Jun 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extensively hydrolyzed rice protein formula in people with Milk Hypersensitivity and Food Sensitivity, run by United Pharmaceuticals at 1 site in Belgium.
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 2 inclusion and 5 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 28 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 1 site in Belgium. 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?
Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score (time frame: at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01998074, which also lists 1 linked publication.
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 28 Nov 2013.