NCT06481280Active, not recruiting
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA
Source: ClinicalTrials.gov · Last updated 7 Jan 2025
Brief summary (registry, in English)
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients. This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital. If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 20 Jun 2024
- Start date
- 14 Aug 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- United Pharmaceuticals
- NCT number
- NCT06481280
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 14 Aug 2024 to the primary completion date, Jan 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- between 1 and 24 months old
- having a CMA proven in the last 3 months prior to inclusion
- free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
- whose parent(s)/legal guardian(s) signed the informed consent form.
- Main Exclusion Criteria:
- Children mainly (\>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
- Children with a mean formula intake lower than 250 ml/day
- Children with past anaphylactic reaction(s)
- Children with chronic (non acute) FPIES
- \-- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject,
- Children already participating in another clinical trial
Age in the registry: 1 month to 24 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Private practice Elena BRADATAN Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| University Hospital - Umberto I Sapienza Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.