Cow's Milk AllergyPhase 2NCT02536482
Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy
A Phase 2 study testing Amix in people with Cow's Milk Allergy, run by Edetec Indústria Alimentícia S.A..
Trial summary
It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Amix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Jun 2015
- Phase
- Phase 2
- 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 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with cow's milk allergy
Who cannot join
- Children without cow's milk allergy
About this study
Official title: Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.
Read the detailed description
In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.
- Conditions
- Cow's Milk Allergy
- Being tested
- Amix
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmixDietary supplement
Treat the children with cow's milk allergy for 5 months.
| Study group | Role | What they receive |
|---|---|---|
| Amix | Experimental | Dietary supplement. The formula is based in free amino-acid to treat children with cow's milk allergy. The children should have a minimum consumption of 400 mL, daily. Receives: Dietary Supplement: Amix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study to assess the allergic symptoms, using a questionnaire.
The allergic symptoms were assessed every month, by using a questionnaire. The parents, during the medical appointment, answered "yes" or "no" according to the presented symptoms: cutaneous (atopic dermatitis and urticaria), gastrointestinal (vomiting, diarrhea constipation and bloody stools ) and respiratory. At the end of the study the children were evaluated if they tolerated the formula, it was observed by the symptoms remission.
Measured: 5 months
Secondary outcomes (3)
Weight assessment, using a digital infant scale
Every medical appointment the doctor measured the weight, by using a digital infant scale. The values were plotted in the software WHO Anthro. A curve weight/age was obtained and the children's weight were compared to the standard population's weight, by the z-score.
Measured: 5 months
Height assessment, using an infantometer
Every medical appointment the doctor measured the height by using a digital infant scale. The values were plotted in the software Anthro. A curve height/age was obtained and the children's height were compared to the standard population's height, by the z-score.
Measured: 5 months
Head circumference, using an infant tape measure
Every medical appointment the doctor measured the head circumference by using a infant tape measure. The values were plotted in the software Anthro. A curve head circumference/age was obtained and the children's head circumference were compared to the standard population's head circumference, by the z-score.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionJun 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edetec Indústria Alimentícia S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Faculdade de Ciências Médicas de Minas Gerais, Federal University of Minas Gerais
- Responsible party
- Sponsor
- Investigators
- Wendel O Afonso, Master, Study director, UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536482
- Sponsor's protocol ID
- U1111-1173-4156
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 33006765
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability to a New Free Amino Acid-based Formula in Children With Cow's Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT02536482
- Acronym / sponsor ID
- U1111-1173-4156
- Conditions
- Cow's Milk Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Edetec Indústria Alimentícia S.A.Industry (pharma, biotech, devices)
- Collaborators
- Faculdade de Ciências Médicas de Minas Gerais, Federal University of Minas Gerais
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Aug 2015 (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.
It is a study to assess the tolerance to a new commercially available infant formula in children affected by Cow's Milk Allergy.
Detailed description
In the present study, the children will be followed-up during the treatment with the new formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight, height and symptoms will be evaluated, by a questionnaire and a physical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amix | Experimental | Dietary Supplement: AmixDietary supplement. The formula is based in free amino-acid to treat children with cow's milk allergy. The children should have a minimum consumption of 400 mL, daily. |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with cow's milk allergy
Key exclusion criteria (1 listed)
- Children without cow's milk allergy
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 |
|---|---|---|
| AmixTreat the children with cow's milk allergy for 5 months. | Dietary supplement | Amix |
Primary outcome
Study to assess the allergic symptoms, using a questionnaire.
Time frame: 5 months
The allergic symptoms were assessed every month, by using a questionnaire. The parents, during the medical appointment, answered "yes" or "no" according to the presented symptoms: cutaneous (atopic dermatitis and urticaria), gastrointestinal (vomiting, diarrhea constipation and bloody stools ) and respiratory. At the end of the study the children were evaluated if they tolerated the formula, it was observed by the symptoms remission.
3 secondary outcomes
Weight assessment, using a digital infant scale
Time frame: 5 months
Height assessment, using an infantometer
Time frame: 5 months
Head circumference, using an infant tape measure
Time frame: 5 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 31 Aug 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.
Related trials for Cow's Milk Allergy
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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.
Wendel O Afonso, Master study director
UFMG
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amix in people with Cow's Milk Allergy, run by Edetec Indústria Alimentícia S.A..
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 1 inclusion and 1 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 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Study to assess the allergic symptoms, using a questionnaire. (time frame: 5 months). 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 NCT02536482, 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 31 Aug 2015.