Trials / Completed
CompletedNCT03557671
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- United Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Month – 36 Months
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.
Detailed description
The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo. The second part of the trial consists in an open phase during which all infants will be fed with the study formula.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | rice formula | new rice based thickened formula |
| DIETARY_SUPPLEMENT | placebo | formula previously tolerated by the subject - only for the 1st part of the study |
Timeline
- Start date
- 2018-08-23
- Primary completion
- 2020-09-21
- Completion
- 2020-09-21
- First posted
- 2018-06-15
- Last updated
- 2020-11-04
Locations
4 sites across 3 countries: Belgium, France, Italy
Source: ClinicalTrials.gov record NCT03557671. Inclusion in this directory is not an endorsement.