Protein AllergyALLARNCT01985607
Efficacy of a New Thickened Extensively Hydrolyzed Formula
A study testing new extensively hydrolysed formula and Extensively hydrolysed formula in people with Protein Allergy and Cow's Milk Protein Hypersensitivity, run by United Pharmaceuticals at 5 sites in 5 countries.
Trial summary
Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Protein Allergy, Cow's Milk Protein Hypersensitivity
- What is being tested?
- new extensively hydrolysed formula and Extensively hydrolysed formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Feb 2011to Dec 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- term born infants
- Having a Vandenplas' score of regurgitation of at least 2
- With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test
Who cannot join
- Exclusively breast fed infants
- Fed with an extensively hydrolysed formula or amino acid formula
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity
Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) \& the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .
This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.
- Being tested
- new extensively hydrolysed formula, Extensively hydrolysed formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new extensively hydrolysed formulaDietary supplement
Extensively hydrolysed formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Thickened | Experimental | Not described Receives: Dietary Supplement: new extensively hydrolysed formula |
| Control | Active comparator | Not described Receives: Dietary Supplement: Extensively hydrolysed formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient dropped out for intolerance
Measured: 1 month
Vandenplas' regurgitations score
Measured: 1 month
Secondary outcomes (5)
Cow's milk protein hypersensitivity score
Measured: 1 month
Growth (weight, height, head circumference)
Measured: 1 month
Growth (weight, height, head circumference)
Measured: 3 months
Growth (weight, height, head circumference)
Measured: 6 months
Number of daily regurgitations
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein AllergyStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985607
- Sponsor's protocol ID
- UP08-ALLAR
- Acronym
- ALLAR
- Status last verified
- Mar 2015
- First submitted
- 8 Nov 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity
- ClinicalTrials.gov ID
- NCT01985607
- Acronym / sponsor ID
- ALLAR / UP08-ALLAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 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.
Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) \& the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .
This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thickened | Experimental | Dietary Supplement: new extensively hydrolysed formula |
| Control | Active comparator | Dietary Supplement: Extensively hydrolysed formula |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- term born infants
- Having a Vandenplas' score of regurgitation of at least 2
- With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test
Key exclusion criteria (2 listed)
- Exclusively breast fed infants
- Fed with an extensively hydrolysed formula or amino acid formula
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 |
|---|---|---|
| new extensively hydrolysed formula | Dietary supplement | Thickened |
| Extensively hydrolysed formula | Dietary supplement | Control |
Primary outcome
Number of patient dropped out for intolerance
Time frame: 1 month
Vandenplas' regurgitations score
Time frame: 1 month
5 secondary outcomes
Cow's milk protein hypersensitivity score
Time frame: 1 month
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
Number of daily regurgitations
Time frame: 1 month
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 24 Mar 2015.
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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.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new extensively hydrolysed formula and Extensively hydrolysed formula in people with Protein Allergy and Cow's Milk Protein Hypersensitivity, run by United Pharmaceuticals at 5 sites in 5 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 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: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Greece, Kuwait, Lebanon, Slovenia. 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?
Number of patient dropped out for intolerance (time frame: 1 month). The study lists 2 primary outcomes in all. 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 24 Mar 2015.