Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Statitec | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRHF - Placebo | Experimental | Each subjects will receive both TRHF and placebo formula during the 1st part of the study |
|
| Placebo - TRHF | Placebo Comparator | Each subjects will receive both TRHF and placebo formula during the 1st part of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rice formula | Dietary Supplement | new rice based thickened formula |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roberto Berni Canani | University Federico II | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Namur | Namur | Belgium | ||||
| Hôpital Saint Vincent de Paul - GHICL |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Dietary Supplement | formula previously tolerated by the subject - only for the 1st part of the study |
|
(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 |
| Lille |
| 59000 |
| France |
| Hopital Trousseau | Paris | France |
| University of Naples Federico II | Naples | Italy |