Cow's Milk AllergyGRITO-14NCT02405923
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
A study testing HRF and eHF in people with Cow's Milk Allergy, run by Laboratorios Ordesa at 5 sites in 2 countries.
Trial summary
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy… Read more about this study
- Who is it for?
- Ages Up to 10 months
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- HRF and eHF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 2014to 11 Apr 2019
- 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 Up to 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study:
- Negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates)
- Negative or positive specific IgE for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk)
- Negative or positive Milk Atopy Patch Test
- Positive Double Blind Placebo Control Food Challenge (DBPCFC) with cow milk
- Gestational Age 37-42 weeks inclusive
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- Apgar SCORE >7 at 5 minutes
- Singleton birth
- Birth weight ≥2.500 g
- Written informed consent
Who cannot join
- Previous signs of allergy to any extensively hydrolysed formula
- Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group
- Daily formula intake < 100 ml
- Major congenital malformations or neonatal diseases
- Severe concurrent or chronic diseases
- Intrauterine growth retardation
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- Neonatal infections ( e.g. CMV, HIV)
- Simultaneous participation in other clinical trials
- Parents not signing written informed consent
- Unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers.
- Liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Spain3 sites
Hospital Materno Infantil de Málaga
Málaga
Hospital Infantil Virgen del Rocío
Seville, Andalusia, 41013
Hospital Universitari i Politècnic La Fe
Valencia, 46026
France2 sites
Hôpital Saint Vincent-de-Paul
Lille, Lille Cedex, 59020
Hôpital Necker-Enfants Malades
Paris, Cedex 14, 75674
About this study
Official title: Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).
Read the detailed description
The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.
- Conditions
- Cow's Milk Allergy
- Being tested
- HRF, eHF
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRFOther
Also called HRF-1 from 0 to 6 months of age, HRF-2 from 6 months of age onwards
The subject will take the formula for a period of 12 months.
eHFOther
Also called eHF-1 from 0 to 6 months of age, eHF-2 from 6 months of age onwards
The subject will take the formula for a period of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| HRF (Rice formula) | Experimental | Hydrolyzed Rice Protein Formula (HRF) Receives: Other: HRF |
| eHF (Extensive Hydrolysed Formula) | Placebo comparator | Extensive Hydrolysed Cow's Milk Protein Formula (eHF) Receives: Other: eHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growing change
To evaluate the children growth using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of CMPA.
Measured: 6 months
Secondary outcomes (3)
Nutritional adequacy
To monitor nutritional adequacy in terms of anthropometrics and proteic status.
Measured: 6 months
Contaminants
To monitor the presence of possible contaminants in urine and hair samples coming from both infant formula groups (only in children exclusively or predominantly formula fed; ideally recruited from 0 to 6 months). Moreover the presence of possible contaminants will be evaluated also in powder formula and formula from baby bottles (only in 12 patients, randomly chosen).
Measured: 6 months
Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)
To evaluate the acquisition of tolerance between both groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start1 Jul 2014
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Why it stopped: recruitment longer than expected and without the expected success
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Mireia Mireia, MD, Principal investigator, Laboratorios Ordesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405923
- Sponsor's protocol ID
- GRITO-14
- Acronym
- GRITO-14
- Status last verified
- Jul 2019
- First submitted
- 13 Nov 2014
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT02405923
- Acronym / sponsor ID
- GRITO-14 / GRITO-14
- Conditions
- Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment longer than expected and without the expected success
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 1 Apr 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.
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).
Detailed description
The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRF (Rice formula) | Experimental | Other: HRFHydrolyzed Rice Protein Formula (HRF) |
| eHF (Extensive Hydrolysed Formula) | Placebo comparator | Other: eHFExtensive Hydrolysed Cow's Milk Protein Formula (eHF) |
Who may qualify
- Ages
- Up to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study:
- Gestational Age 37-42 weeks inclusive
- Apgar SCORE >7 at 5 minutes
- Singleton birth
- Birth weight ≥2.500 g
Key exclusion criteria (11 listed)
- Previous signs of allergy to any extensively hydrolysed formula
- Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group
- Daily formula intake < 100 ml
- Major congenital malformations or neonatal diseases
- Severe concurrent or chronic diseases
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 |
|---|---|---|
| HRFAlso: HRF-1 from 0 to 6 months of age, HRF-2 from 6 months of age onwardsThe subject will take the formula for a period of 12 months. | Other | HRF (Rice formula) |
| eHFAlso: eHF-1 from 0 to 6 months of age, eHF-2 from 6 months of age onwardsThe subject will take the formula for a period of 12 months. | Other | eHF (Extensive Hydrolysed Formula) |
Primary outcome
Growing change
Time frame: 6 months
To evaluate the children growth using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of CMPA.
3 secondary outcomes
Nutritional adequacy
Time frame: 6 months
Contaminants
Time frame: 6 months
Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: recruitment longer than expected and without the expected success). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
Mireia Mireia, MD principal investigator
Laboratorios Ordesa
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRF and eHF in people with Cow's Milk Allergy, run by Laboratorios Ordesa at 5 sites in 2 countries.
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 10 inclusion and 11 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 18 Jul 2019. 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 Spain, 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. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment longer than expected and without the expected success). 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?
Growing change (time frame: 6 months). 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 18 Jul 2019.