Cow's Milk AllergyNCT01584245
Evaluation of the Efficacy of an Amino Acid Based Formula in Infants
A study testing Amino Acid formula in people with Cow's Milk Allergy, run by Mead Johnson Nutrition at 5 sites in France.
Trial summary
This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Amino Acid formula
- How many people
- 32 participants
- Where
- 5 sitesFrance
- Study dates
- Feb 2012to Jul 2014
- 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 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight loss within the past 4 weeks
- Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
- Birth weight greater than or equal to 1500 grams
- Solely enteral fed
- Infants with at least one persistent allergy symptom
- No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
- Signed informed consent
Who cannot join
- History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
- Metabolic disease requiring special attention
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre médical
Boulogne-Billancourt
Hôpital Saint Vincent de Paul
Lille
Hôpital Armand Trousseau
Paris
Hôpital Necker Enfants Malades
Paris
Médecine Infantile 1
Vandoeuvre Lés Nancy
About this study
This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.
- Conditions
- Cow's Milk Allergy
- Being tested
- Amino Acid formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid formulaOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 12 weeks
Secondary outcomes (1)
Allergic manifestations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Enough participants enrolled to provide adequate statistical power
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 Cow's 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Delphine de Boissieu, M.D., Principal investigator, Centre médical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584245
- Sponsor's protocol ID
- 6009
- Status last verified
- Sep 2014
- First submitted
- 23 Apr 2012
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533. doi: 10.1097/MPG.0000000000001374.
PubMed 27526059
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of an Amino Acid Based Formula in Infants
- ClinicalTrials.gov ID
- NCT01584245
- Acronym / sponsor ID
- 6009
- Conditions
- Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enough participants enrolled to provide adequate statistical power
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Apr 2012 (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.
This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Weight loss within the past 4 weeks
- Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
- Birth weight greater than or equal to 1500 grams
- Solely enteral fed
- Infants with at least one persistent allergy symptom
Key exclusion criteria (2 listed)
- History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
- Metabolic disease requiring special attention
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 formula | Other | – |
Primary outcome
Weight gain
Time frame: 12 weeks
1 secondary outcome
Allergic manifestations
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Enough participants enrolled to provide adequate statistical power). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Derived from this study: PubMed 27526059Vanderhoof J, Moore N, de Boissieu D. Evaluation of an Amino Acid-Based Formula in Infants Not Responding to Extensively Hydrolyzed Protein Formula. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):531-533. doi: 10.1097/MPG.0000000000001374.
Related trials for Cow's Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Cow's Milk Allergy
RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
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.
Delphine de Boissieu, M.D. principal investigator
Centre médical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid formula in people with Cow's Milk Allergy, run by Mead Johnson Nutrition at 5 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 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: stopped early, as of the sponsor's last update on 16 Sep 2014. 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 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 was stopped early (reason given: Enough participants enrolled to provide adequate statistical power). Results are not available in the source record.
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?
Weight gain (time frame: 12 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 NCT01584245, 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 16 Sep 2014.