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New treatment option for IgE-Mediated Cow Milk Allergy
Official title Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
ClinicalTrials.gov ID: NCT07197814
What this study is testing
- What it's testing
- The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered " hypoallergenic ".
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 36
You may be able to join if
- Infants and young children between 1 and 36 months of age
- Consuming at least 240 ml/day of formula
- Gestational age ≥ 37 weeks
- Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
- Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment
You likely can't join if
- Infant is exclusively breastfed.
- Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
- Major gastrointestinal disease/abnormalities (other than CMA).
- Other food allergies
- Eosinophilic disorders of the gastrointestinal tract.
- Evidence of non-IgE-mediated CMA.
See the full eligibility criteria
- Infants and young children between 1 and 36 months of age
- Consuming at least 240 ml/day of formula
- Gestational age ≥ 37 weeks
- Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
- Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment
- Observing a strict cow's milk proteins elimination diet for at least 4 weeks prior to study enrollment
- Parents or legal guardians agree not to enroll infant in another treatment clinical study while participating in this study
- Written informed consent form obtained from both parents (or legally acceptable representative [LAR], if applicable)
- Infant's parents / LAR are of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study...
- Signed authorization obtained from both parents or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period
- Infant is exclusively breastfed.
- Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
- Major gastrointestinal disease/abnormalities (other than CMA).
- Other food allergies
- Eosinophilic disorders of the gastrointestinal tract.
- Evidence of non-IgE-mediated CMA.
- Immunodeficiency.
- Use of drugs that may interfere with the interpretation and safety of the SPT procedure planned on Inclusion visit such as antihistamines and topical corticosteroids in the previous week, angiotensin-converting enzyme...
- Previous use of systemic immunomodulatory treatment at any time before study entry.
- Use of systemic antibiotics or anti-mycotic drugs within 4 weeks before study entry.
- Persistent wheeze or chronic respiratory disease.
- Severe uncontrolled eczema.
- Currently participating or having participated in another treatment clinical study within 4 weeks prior to enrollment.
- Infant's parents/LAR have medical or psychiatric condition that, in the judgement of the Investigator, would make the subject inappropriate for entry into the study.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 36 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.