Cow Milk Protein SensitivityPhase 2JUNGLONCT01909661
Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas
A Phase 2 study testing Damira/Celia peptide hydrolyzed casein and Picot riz/Celia rice/Sanutri arroz in people with Cow Milk Protein Sensitivity and Tolerance, run by Lactalis at 1 site in Spain.
Trial summary
The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms… Read more about this study
- Who is it for?
- Ages Up to 9 months
- Conditions the study is for
- Cow Milk Protein Sensitivity, Tolerance, Growth Failure
- What is being tested?
- Damira/Celia peptide hydrolyzed casein and Picot riz/Celia rice/Sanutri arroz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Aug 2014
- 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 Up to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full term healthy newborns (37-42 Weeks gestation)
- Weight at birth ≥ 2500 g
- Aged between birth to 9 months
- Symptoms of allergy (Skin or digetive)
- Suspicion of cow milk protein allergy
- Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
- Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study
Who cannot join
- Children who have returned to breastfeeding
- Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
- In the past 15 days, treatment or medication likely to :
- induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
- mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, …)
- Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
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- Children who show signs of malnutrition, or prolonged diarrhea
- Children whose parents show no willingness to comply with study requirements
- Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca
The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.
- Conditions
- Cow Milk Protein Sensitivity, Tolerance, Growth Failure
- Being tested
- Damira/Celia peptide hydrolyzed casein, Picot riz/Celia rice/Sanutri arroz
- Keywords
- allergy, Cow's milk protein, Tolerance, Efficacy, Infants' growth
- Medical subject headings
- Failure to Thrive, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damira/Celia peptide hydrolyzed caseinOther
Picot riz/Celia rice/Sanutri arrozOther
| Study group | Role | What they receive |
|---|---|---|
| Damira/Celia peptide hydrolyzed casein | Experimental | Extensively Hydrolyzed (EH)casein infant formula Receives: Other: Damira/Celia peptide hydrolyzed casein |
| Picot riz/Celia rice/Sanutri arroz | Experimental | Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula Receives: Other: Picot riz/Celia rice/Sanutri arroz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.
Tolerance is absence of clinical signs.
Measured: 24h
Secondary outcomes (1)
Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.
Evaluate during 3 months of consumption the effectiveness of the formulas, in terms of :
- infant growth, through anthropometric measures (body weight, length and head circumference)
- allergy symptoms, through the improvement of the allergy symptoms.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk Protein SensitivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosearch S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909661
- Sponsor's protocol ID
- LRD - 2013 - JUNGLO
- Acronym
- JUNGLO
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca
- ClinicalTrials.gov ID
- NCT01909661
- Acronym / sponsor ID
- JUNGLO / LRD - 2013 - JUNGLO
- Conditions
- Cow Milk Protein Sensitivity, Tolerance, Growth Failure
- Keywords
- allergy, Cow's milk protein, Tolerance, Efficacy, Infants' growth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Collaborators
- Biosearch S.A.
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Jul 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 objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Damira/Celia peptide hydrolyzed casein | Experimental | Other: Damira/Celia peptide hydrolyzed caseinExtensively Hydrolyzed (EH)casein infant formula |
| Picot riz/Celia rice/Sanutri arroz | Experimental | Other: Picot riz/Celia rice/Sanutri arrozPicot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Full term healthy newborns (37-42 Weeks gestation)
- Weight at birth ≥ 2500 g
- Aged between birth to 9 months
- Symptoms of allergy (Skin or digetive)
- Suspicion of cow milk protein allergy
Key exclusion criteria (9 listed)
- Children who have returned to breastfeeding
- Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
- In the past 15 days, treatment or medication likely to :
- Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
- Children who show signs of malnutrition, or prolonged diarrhea
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 |
|---|---|---|
| Damira/Celia peptide hydrolyzed casein | Other | Damira/Celia peptide hydrolyzed casein |
| Picot riz/Celia rice/Sanutri arroz | Other | Picot riz/Celia rice/Sanutri arroz |
Primary outcome
Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.
Time frame: 24h
Tolerance is absence of clinical signs.
1 secondary outcome
Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.
Time frame: 3 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 17 Apr 2015.
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GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
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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 Phase 2 study testing Damira/Celia peptide hydrolyzed casein and Picot riz/Celia rice/Sanutri arroz in people with Cow Milk Protein Sensitivity and Tolerance, run by Lactalis at 1 site in Spain.
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 9 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 17 Apr 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 Spain. 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.
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?
Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption. (time frame: 24h). 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 17 Apr 2015.