An interventional study of Hydrolyzed protein infant formula and commercially available hypoallergenic infant formula in Cow's Milk Allergy, sponsored by Nutricia Research. Suspended at 1 site in Italy. Open to participants aged 0 Days to 3 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Other
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.
The study consists of a double-blind, placebo-controlled food challenge, followed by a single arm open challenge.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 29 is below the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Nutricia Research is the lead sponsor of 51 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
hydrolysed protein formula
Other: Hydrolyzed protein infant formula
commercially available hypoallergenic infant formula
Other: commercially available hypoallergenic infant formula
Hydrolyzed protein infant formula
commercially available hypoallergenic infant formula
Hypoallergenicity
The percentage of children tolerating the formula tested by double-blind, placebo-controlled food challenge and a subsequent open challenge.
Time frame: 25-35 days
Relevant parameters routinely collected in the clinic
e.g serum IgE results
Time frame: 25-35 days
Incidence, seriousness, severity and relatedness of Adverse Events
Safety and tolerance parameters
Time frame: 25-35 days
Demographics characteristics
Demographics characteristics
Time frame: at baseline
Relevant parameters routinely collected in the clinic
e.g. skin prick test results
Time frame: 25-35 days
Birth length
cm
Time frame: at baseline
Birth weight
g
Time frame: at baseline
anthropometrics
e.g. weight and lenght
Time frame: at baseline
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Dec 2026, 29 months later.
How these figures are worked out, and which studies are left out of them.
This study is suspended, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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