Clinical trial NCT03557671: Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow Milk Allergy
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Statitec
First posted: 2018-06-15
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
* free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
* whose parents signed the informed consent

Exclusion Criteria:

* mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject

Primary outcomes:
measure: hypoallergenicity
timeFrame: 7 days
Secondary outcomes:
measure: Regurgitations
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Vomiting
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Abdominal pain
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Bloating and gas
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Stool consistency
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Stool frequency
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Blood in stools
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Sleeping time over 24h satisfaction
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Unexplained crying
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Respiratory symptoms
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Urticaria
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Angioedema
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Eczema
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Weight
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Height
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: BMI
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Head circumference
timeFrame: 1, 2, 3, 4, 5 and 6 months
measure: Number of patients with treatment emergent Adverse Events
timeFrame: 1, 2, 3, 4, 5 and 6 months
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: CHR Namur
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul - GHICL
city: Paris
country: France
facility: Hopital Trousseau
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: University Federico II
name: Roberto Berni Canani
role: STUDY_DIRECTOR
References: