Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Cow Milk Allergy

Intervention / Treatment
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* Dietary Supplement: rice formula
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRHF - Placebo<br>Each subjects will receive both TRHF and placebo formula during the 1st part of the study | Dietary Supplement: rice formula<br>* new rice based thickened formula<br>Dietary Supplement: placebo<br>* formula previously tolerated by the subject - only for the 1st part of the study<br>|
| Placebo Comparator: Placebo - TRHF<br>Each subjects will receive both TRHF and placebo formula during the 1st part of the study | Dietary Supplement: rice formula<br>* new rice based thickened formula<br>Dietary Supplement: placebo<br>* formula previously tolerated by the subject - only for the 1st part of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoallergenicity | the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regurgitations | assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding) | 1, 2, 3, 4, 5 and 6 months | 
| Vomiting | (on a 4 level scale) | 1, 2, 3, 4, 5 and 6 months | 
| Abdominal pain | (severity on a 4 level scale) | 1, 2, 3, 4, 5 and 6 months | 
| Bloating and gas | (severity on a 4 level scale) | 1, 2, 3, 4, 5 and 6 months | 
| Stool consistency | assessed through Bristol Stools Form Scale from Type A ( Separate hard lumps, like nuts (hard to pass)) to Type G (Watery, not solid pieces - entirely liquid ) | 1, 2, 3, 4, 5 and 6 months | 
| Stool frequency | (number of stool per day or per week) | 1, 2, 3, 4, 5 and 6 months | 
| Blood in stools | (presence/absence) | 1, 2, 3, 4, 5 and 6 months | 
| Sleeping time over 24h satisfaction | (presence/absence) | 1, 2, 3, 4, 5 and 6 months | 
| Unexplained crying | (yes/no) | 1, 2, 3, 4, 5 and 6 months | 
| Respiratory symptoms | (severity on a 4 level scale) | 1, 2, 3, 4, 5 and 6 months | 
| Urticaria | (presence/absence) | 1, 2, 3, 4, 5 and 6 months | 
| Angioedema | (presence/absence) | 1, 2, 3, 4, 5 and 6 months | 
| Eczema | severity assessed through SCORAD | 1, 2, 3, 4, 5 and 6 months | 
| Weight | expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards | 1, 2, 3, 4, 5 and 6 months | 
| Height | expressed in cm and in z scores according to the WHO Child Growth Standards | 1, 2, 3, 4, 5 and 6 months | 
| BMI | expressed in value and z scores according to the WHO Child Growth Standards | 1, 2, 3, 4, 5 and 6 months | 
| Head circumference | expressed in cm and in z scores according to the WHO Child Growth Standards | 1, 2, 3, 4, 5 and 6 months | 
| Number of patients with treatment emergent Adverse Events |  | 1, 2, 3, 4, 5 and 6 months |