Cow Milk AllergyNCT01940068
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
A study testing Amino acid based formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas; Read more about this study
- Who is it for?
- Ages 2 weeks to 18 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Amino acid based formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Mar 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 2 weeks to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than 18 months old
- with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (>=6mm) or specific immunoglobulin E >= 5 kilo-unit/L or combination
- still symptomatic while fed an extensively hydrolysed formula
Who cannot join
- Exclusively breast fed infants
- non allergic digestive enteropathy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;
- Conditions
- Cow Milk Allergy
- Being tested
- Amino acid based formula
- Keywords
- Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity
- Medical subject headings
- Milk Hypersensitivity, Hypersensitivity, Immune System Diseases, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid based formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| New Thickened Amino acid based formula | Experimental | Not described Receives: Dietary Supplement: Amino acid based formula |
| Amino acid based formula | Active comparator | Not described Receives: Dietary Supplement: Amino acid based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of withdrawal for intolerance
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 posted11 Sep 2013 (estimated)
- Study startMar 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cow Milk 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940068
- Sponsor's protocol ID
- PRO-UP05-E1
- Status last verified
- Mar 2015
- First submitted
- 6 Sep 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, De Blay F, Guenard-Bilbault L, Hatahet R, Mulier S, Kapel N, Waligora-Dupriet AJ, Butel MJ. Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.
PubMed 25844709Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guenard-Bilbault L, Hatahet R, Mulier S. A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial. Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x.
PubMed 25446768
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
- A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
- ClinicalTrials.gov ID
- NCT01940068
- Acronym / sponsor ID
- PRO-UP05-E1
- Conditions
- Cow Milk Allergy
- Keywords
- Hypersensitivity, Milk Hypersensitivity, Immune System Diseases, Food Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Sep 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 purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Thickened Amino acid based formula | Experimental | Dietary Supplement: Amino acid based formula |
| Amino acid based formula | Active comparator | Dietary Supplement: Amino acid based formula |
Who may qualify
- Ages
- 2 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- less than 18 months old
- with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (>=6mm) or specific immunoglobulin E >= 5 kilo-unit/L or combination
- still symptomatic while fed an extensively hydrolysed formula
Key exclusion criteria (2 listed)
- Exclusively breast fed infants
- non allergic digestive enteropathy
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 |
|---|---|---|
| Amino acid based formula | Dietary supplement | Amino acid based formula, New Thickened Amino acid based formula |
Primary outcome
Number of withdrawal for intolerance
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.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
- Derived from this study: PubMed 25844709Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, De Blay F, Guenard-Bilbault L, Hatahet R, Mulier S, Kapel N, Waligora-Dupriet AJ, Butel MJ. Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.
- Derived from this study: PubMed 25446768Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guenard-Bilbault L, Hatahet R, Mulier S. A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial. Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x.
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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 Amino acid based formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 1 site 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 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 1 site 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.
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 withdrawal for intolerance (time frame: 1 month). 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 NCT01940068, which also lists 3 linked publications.
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.