Cow Milk Allergy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTrice formula
new rice based thickened formula
DIETARY_SUPPLEMENTplacebo
formula previously tolerated by the subject - only for the 1st part of the study
Sponsors
Statitec
United Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hypoallergenicity | 7 days | the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vomiting | 1, 2, 3, 4, 5 and 6 months | (on a 4 level scale) |
| Abdominal pain | 1, 2, 3, 4, 5 and 6 months | (severity on a 4 level scale) |
| Bloating and gas | 1, 2, 3, 4, 5 and 6 months | (severity on a 4 level scale) |
| Stool consistency | 1, 2, 3, 4, 5 and 6 months | 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 ) |
| Stool frequency | 1, 2, 3, 4, 5 and 6 months | (number of stool per day or per week) |
| Blood in stools | 1, 2, 3, 4, 5 and 6 months | (presence/absence) |
| Sleeping time over 24h satisfaction | 1, 2, 3, 4, 5 and 6 months | (presence/absence) |
| Unexplained crying | 1, 2, 3, 4, 5 and 6 months | (yes/no) |
| Regurgitations | 1, 2, 3, 4, 5 and 6 months | assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding) |
| Urticaria | 1, 2, 3, 4, 5 and 6 months | (presence/absence) |
| Angioedema | 1, 2, 3, 4, 5 and 6 months | (presence/absence) |
| Eczema | 1, 2, 3, 4, 5 and 6 months | severity assessed through SCORAD |
| Weight | 1, 2, 3, 4, 5 and 6 months | expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards |
| Height | 1, 2, 3, 4, 5 and 6 months | expressed in cm and in z scores according to the WHO Child Growth Standards |
| BMI | 1, 2, 3, 4, 5 and 6 months | expressed in value and z scores according to the WHO Child Growth Standards |
| Head circumference | 1, 2, 3, 4, 5 and 6 months | expressed in cm and in z scores according to the WHO Child Growth Standards |
| Number of patients with treatment emergent Adverse Events | 1, 2, 3, 4, 5 and 6 months | — |
| Respiratory symptoms | 1, 2, 3, 4, 5 and 6 months | (severity on a 4 level scale) |
Countries
Belgium, France, Italy
Outcome results
None listed