Cow Milk AllergyPhase 3ALYCENCT02711163
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
A Phase 3 study testing Extensively Hydrolyzed formula and Amino acid formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 1 site in Italy.
Trial summary
The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Extensively Hydrolyzed formula and Amino acid formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to 29 Nov 2017
- Phase
- Phase 3
- 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 36 months
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
Infants:
- with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
- successfully fed an eviction diet for at least 2 weeks
Main Non-inclusion Criteria:
Infants:
- fed with an extensively hydrolyzed formula with no improvement of the symptoms,
- who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
- fed a vegetable based formula
- fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
- 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 Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy
The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.
- Conditions
- Cow Milk Allergy
- Being tested
- Extensively Hydrolyzed formula, 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.
Extensively Hydrolyzed formulaDietary supplement
Amino acid formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Extensively hydrolyzed formula | Experimental | Feeding extensively hydrolyzed formula Receives: Dietary Supplement: Extensively Hydrolyzed formula |
| Amino acid formula | Placebo comparator | Feeding amino acid formula Receives: Dietary Supplement: Amino acid formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
Measured: 7 days
Secondary outcomes (17)
Regurgitation assessed through Vandenplas score
Measured: 7, 45 and 90 days
Vomiting (weekly frequency)
Measured: 7, 45 and 90 days
Abdominal pain (severity on a 4 level scale)
Measured: 7, 45 and 90 days
Bloating and gas (severity on a 4 level scale)
Measured: 7, 45 and 90 days
Stool consistency assessed through Bristol Stools Form Scale
Measured: 7, 45 and 90 days
Sleeping time over 24h
Measured: 7, 45 and 90 days
Stool frequency over 72h
Measured: 7, 45 and 90 days
Blood in stools (presence/absence)
Measured: 7, 45 and 90 days
Duration of crying over 24h
Measured: 7, 45 and 90 days
Respiratory symptoms (severity on a 4 level scale)
Measured: 7, 45 and 90 days
Urticaria (presence/absence)
Measured: 7, 45 and 90 days
Eczema assessed through SCORAD
Measured: 7, 45 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Measured: 45 and 90 days
Height expressed in z scores according to the WHO Child Growth Standards
Measured: 45 and 90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Measured: 45 and 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Measured: 45 and 90 days
Number of patients with treatment emergent Adverse Events
Measured: 7, 45 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion31 Aug 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salvatore Cucchiara, Principal investigator, University Hospital Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711163
- Sponsor's protocol ID
- UP-2014-02-ALYCE
- Acronym
- ALYCE
- Status last verified
- May 2018
- First submitted
- 8 Mar 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hypoallergenicity of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow's Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT02711163
- Acronym / sponsor ID
- ALYCE / UP-2014-02-ALYCE
- Conditions
- Cow Milk Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 17 Mar 2016 (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 this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extensively hydrolyzed formula | Experimental | Dietary Supplement: Extensively Hydrolyzed formulaFeeding extensively hydrolyzed formula |
| Amino acid formula | Placebo comparator | Dietary Supplement: Amino acid formulaFeeding amino acid formula |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 formula | Dietary supplement | Extensively hydrolyzed formula |
| Amino acid formula | Dietary supplement | Amino acid formula |
Primary outcome
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge
Time frame: 7 days
17 secondary outcomes
Regurgitation assessed through Vandenplas score
Time frame: 7, 45 and 90 days
Vomiting (weekly frequency)
Time frame: 7, 45 and 90 days
Abdominal pain (severity on a 4 level scale)
Time frame: 7, 45 and 90 days
Bloating and gas (severity on a 4 level scale)
Time frame: 7, 45 and 90 days
Stool consistency assessed through Bristol Stools Form Scale
Time frame: 7, 45 and 90 days
Sleeping time over 24h
Time frame: 7, 45 and 90 days
Stool frequency over 72h
Time frame: 7, 45 and 90 days
Blood in stools (presence/absence)
Time frame: 7, 45 and 90 days
Duration of crying over 24h
Time frame: 7, 45 and 90 days
Respiratory symptoms (severity on a 4 level scale)
Time frame: 7, 45 and 90 days
Urticaria (presence/absence)
Time frame: 7, 45 and 90 days
Eczema assessed through SCORAD
Time frame: 7, 45 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
Height expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time frame: 45 and 90 days
Number of patients with treatment emergent Adverse Events
Time frame: 7, 45 and 90 days
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 15 May 2018.
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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.
Salvatore Cucchiara principal investigator
University Hospital Umberto I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extensively Hydrolyzed formula and Amino acid formula in people with Cow Milk Allergy, run by United Pharmaceuticals at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 May 2018. 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 Italy. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge (time frame: 7 days). 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 15 May 2018.