Allergy;FoodCHARMNCT04519827
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
A study testing New Rice-based hydrolysate and Amino Acid-based infant formula in people with Allergy;Food, run by Dr. Schär AG / SPA at 4 sites in 2 countries.
Trial summary
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Allergy;Food
- What is being tested?
- New Rice-based hydrolysate and Amino Acid-based infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 21 May 2020to 29 Nov 2023
- 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 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children <10 yrs of age
- Proven IgE-mediated CMA
- >2500g at birth
- > 37 weeks gestation
- Written informed consent provided by parent(s)/guardian
Who cannot join
- Infants/children with severe concurrent illness (other than food allergy/CMA)
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study
- Current participation in OIT to Cow's Milk
- Diagnosis of anaphylaxis to Cow's Milk
- Diagnosis of rice allergy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Italy3 sites
Meyer Children's Hospital
Florence, 50139
Spett.le Universita degli Studi di Napoli ''Federico II''
Naples, 80131
Hospital Infantile Regina Margherita.
Turin, 10126
Spain1 site
Hospital Sant Joan de Déu Barcelona 2020,
Barcelona, 08950 Esplugues de Llobregat,
About this study
Official title: A Prospective, Randomised, Double-blind Controlled Study, to Evaluate the Safety/Hypoallergenicity of a New Rice-based Hydrolysate Formula With New Ingredient for Infants and Children With Diagnosed Cow's Milk Allergy
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.
Read the detailed description
A prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed Cow's Milk Allergy (CMA). The test product being a new milk substitute hydrolysed rice-based formula with new ingredient. The results will satisfy the safety requirement when tolerated by 90% of children with proven CMA, with a confidence of 95%. New, and previously diagnosed children with confirmed CMA who meet the inclusion criteria will be eligible to participate in the study. Those included in the intervention phase will have IgE testing and an oral food challenge (OFC) to test and placebo products, in a randomised double-blind design. Children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge).
- Conditions
- Allergy;Food
- Being tested
- New Rice-based hydrolysate, Amino Acid-based infant formula
- Keywords
- Cow's Milk Protein Allergy (CMPA), Cow's Milk Allergy (CMA), CHILDREN
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Rice-based hydrolysateOther
A rice-based hydrolysed infant formula with new ingredient
Amino Acid-based infant formulaOther
An amino acid-based infant formula
| Study group | Role | What they receive |
|---|---|---|
| New Rice-based hydrolysate | Experimental | The TEST formula is a new Rice-based hydrolysate with new ingredient. Receives: Other: New Rice-based hydrolysate |
| Amino-acid based formula | Placebo comparator | The PLACEBO is an Amino-acid based formula. Receives: Other: Amino Acid-based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoallergenicity
90% of children tolerate the TEST formula with a 95% CI - using the double blind placebo controlled food challenge and open challenge (Test vs. placebo).
Measured: 7 days open challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start21 May 2020
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy;FoodStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Schär AG / SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519827
- Sponsor's protocol ID
- CHARM-01-2020
- Acronym
- CHARM
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Double-blind Controlled Study, to Evaluate the Safety/Hypoallergenicity of a New Rice-based Hydrolysate Formula With New Ingredient for Infants and Children With Diagnosed Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT04519827
- Acronym / sponsor ID
- CHARM / CHARM-01-2020
- Conditions
- Allergy;Food
- Keywords
- Cow's Milk Protein Allergy (CMPA), Cow's Milk Allergy (CMA), CHILDREN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Dr. Schär AG / SPAIndustry (pharma, biotech, devices)
- Study start
- 21 May 2020 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- 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.
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. Breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with CMA maternal dairy exclusion is recommended as first line treatment. In non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. The AAP and other societies such as EAACI and ESPGHAN considers a formula to be 'hypoallergenic' if at least 90% of children with documented CMA tolerate it, with a 95% CI, under double-blind, placebo-controlled conditions.This equates to at least 29 children who should tolerate the product following blind and open challenge.
Detailed description
A prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed Cow's Milk Allergy (CMA). The test product being a new milk substitute hydrolysed rice-based formula with new ingredient. The results will satisfy the safety requirement when tolerated by 90% of children with proven CMA, with a confidence of 95%. New, and previously diagnosed children with confirmed CMA who meet the inclusion criteria will be eligible to participate in the study. Those included in the intervention phase will have IgE testing and an oral food challenge (OFC) to test and placebo products, in a randomised double-blind design. Children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Rice-based hydrolysate | Experimental | Other: New Rice-based hydrolysateThe TEST formula is a new Rice-based hydrolysate with new ingredient. |
| Amino-acid based formula | Placebo comparator | Other: Amino Acid-based infant formulaThe PLACEBO is an Amino-acid based formula. |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children <10 yrs of age
- Proven IgE-mediated CMA
- >2500g at birth
- > 37 weeks gestation
- Written informed consent provided by parent(s)/guardian
Key exclusion criteria (6 listed)
- Infants/children with severe concurrent illness (other than food allergy/CMA)
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- Participation in other studies involving use of milk replacement products designed to treat/manage CMA within two weeks prior to entry into this study
- Current participation in OIT to Cow's Milk
- Diagnosis of anaphylaxis to Cow's Milk
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 |
|---|---|---|
| New Rice-based hydrolysateA rice-based hydrolysed infant formula with new ingredient | Other | New Rice-based hydrolysate |
| Amino Acid-based infant formulaAn amino acid-based infant formula | Other | Amino-acid based formula |
Primary outcome
Hypoallergenicity
Time frame: 7 days open challenge
90% of children tolerate the TEST formula with a 95% CI - using the double blind placebo controlled food challenge and open challenge (Test vs. placebo).
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 8 Dec 2023.
- Individual participant dataSharing planned: No
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Rice-based hydrolysate and Amino Acid-based infant formula in people with Allergy;Food, run by Dr. Schär AG / SPA at 4 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 5 inclusion and 6 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, 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. 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 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?
Hypoallergenicity (time frame: 7 days open challenge). 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 8 Dec 2023.